Download PDF

Clinical Trial Results:
Near infrared imaging and measurement of extremity lymphatic collector function using indocyanine green

Summary
EudraCT number	2013-004954-58
Trial protocol	DK
Global end of trial date	06 Jun 2017

Results information
Results version number	v1(current)
This version publication date	24 Mar 2020
First version publication date	24 Mar 2020
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

2013-617

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Bispebjerg & Frederiksberg Hospital, Capital Region of Denmark

Sponsor organisation address

Ebba Lunds Vej 44, Copenhagen NW, Denmark, 2400

Public contact

Department of Clinical Physiology & Nuclear Medicine, Bispebjerg & Frederiksberg Hospital, 0045 3863 5530, mads.radmer.jensen@regionh.dk

Scientific contact

Department of Clinical Physiology & Nuclear Medicine, Bispebjerg & Frederiksberg Hospital, 0045 3863 5530, mads.radmer.jensen@regionh.dk

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

03 Jan 2020

Is this the analysis of the primary completion data?

Yes

Primary completion date

06 Jun 2017

Global end of trial reached?

Yes

Global end of trial date

06 Jun 2017

Was the trial ended prematurely?

Yes

Main objective of the trial

To assess effects of method variations and physical factors on visualisation of numbers of - and pumping activity in extremity lymphatic collectors in healthy adult subjects using indocyanine green (ICG) fluorescence lymphangiography.

Protection of trial subjects

During the study visit: - Discomfort/pain: To avoid precipitation in the injectate, ICG powder was dissolved in sterile water for injection purposes. However, this solution is hypotonic, and skin injection is therefore painful. This was alleviated by first dissolving ICG in 1 ml sterile water for injection purposes with subsequent dilution with sterile isotonic saline for injection purposes to the desired concentration. - Infection: Although the risk of skin infection related to injection of the ICG solution is expectedly minor in healthy subjects, the following measures were taken to further reduce the risk: 1) ICG was reconstituted using sterile technique, 2) Depot injection sites were disinfected twice with alcohol swaps prior to injection, 3) Sterile disposable needles and - syringes were used. - Acute adverse events and - reactions: Following depot injection and during the imaging procedure (minimum 180 min after 1. and 90 min after last injection) the subjects were monitored clinically for signs of acute local or systemic allergic reactions. None occurred, however if a reaction had occurred treatment and monitoring would have followed manufacturer (See SPC) and hospital guidelines. Necessary acute medication and utensils were always readily at hand in the study department. After the study visit: The subject was instructed to contact the primary investigator in case of suspected late adverse events and/or - reactions. One week after participation the subject participated in a short mandatory phone interview in order to identify any unrecognised adverse events or - reactions. None occurred; however, if an adverse reaction had been suspected, the subject would have been examined clinically and the event documented in detail in the CRF. Absence of adverse events or - reactions was specifically recorded in the CRF. Treatment, follow-up and/or referral – if necessary – would have been decided on a case-by-case basis

Background therapy

None

Evidence for comparator

Evidence has been published showing that skin injections of the fluorescent dye Indocyanine green (ICG) enable near infrared imaging of extremity lymphatic collectors. Through video analysis dynamics of peristaltic pumping activity in these collectors is possible. However, sparse evidence exists in the literature on the possible effects of study method variations, subject characteristics and physical factors on numbers of visualised lymphatic collectors and their pumping activity (lymph package frequency) in healthy adult subjects with normal Body Mass Index. Hence, this study is exploratory in nature and designed to elucidate possible large effects of below listed factors. The results may prove important to take into account in the design of future trials. Method variations (Group A): - Time delay from depot injection to imaging: 0 min, 30 min, 120 min and 150 min. - Injection method: Intradermal vs subcutaneous. - Injected volume: 0,1 ml vs 0,3 ml. - Injected concentration: 0,83 mg/ml, 1 mg/ml and 2,5 mg/ml. - Extremity: Depot injection interdigitally on the dorsum of the hand vs the foot. Physical factors (Group B*): - External skin heating: Heating lamp adjusted to 39 degrees centigrade skin temperature. - Exercise: Treadmill walking at 4 km/h in 10 min. - Tonicity of injectate: Sterile water dilution of the injectate vs dilution with isotonic saline. - Venous stasis: Depot dependency 30 cm below heart level. Other factors: - Age - Gender *Note: Data collection i group A was completed. It was our intend - according to protocol - to perform an interim analysis of the data acquired in group A. Based on these results we planned to choose the method to be applied in group B. However, due to lack of personnel resources the study was interrupted in the interim analysis period. Group B was never initiated.

Actual start date of recruitment

03 Feb 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Denmark: 19

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Volunteers were recruited from the Capital Region of Denmark by approved advertisement on the website http://www.forsøgsperson.dk. Interested subjects contacted the subinvestigator by e-mail or phone. Written informed consent was obtained prior to participation. The first subject was recruited on 30.12.2014 and the last on 06.06.2017

Screening details

Inclusion: - Healthy - Capable - Age 18-65 years - BMI 18-25 kg/m2 - A negative urine-HCG test for fertile women Exclusion: - Any known disease or chronic medication - Pregnancy or lactation - Contraindication to ICG-PULSION® use (see SPC). - Smoking/other nicotine use. - Oedema, venous disease, local inflammation.

Period 1 title

Overall trail (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Blinding implementation details

None

Group A

Arm description

Effect of method variations on numbers of visualised lymphatic collectors and their pumping activity. Assessed factors are: - Time delay from depot injection to imaging: 0 min, 30 min, 120 min and 150 min. - Injectate concentration: 0,1 mg/ml, 0,83 mg/ml and 2,5 mg/ml. - Injected volume: 0,1 ml and 0,3 ml. - Skin injection method: Intradermal and subcutaneous. Other explanatory factors: Gender, age and extremity (arm and leg).

Arm type

Experimental

Investigational medicinal product name

ICG-PULSION(R)

Investigational medicinal product code

Other name

Indocyanine Green

Pharmaceutical forms

Powder for concentrate for solution for injection/infusion

Routes of administration

Intradermal use, Subcutaneous use

Dosage and administration details

Sterile utensils and techniques were used. One vial of ICG-PULSION® was used for each subject. A base solution was prepared by reconstituting 25 mg ICG powder with 1 ml sterile water for injection purposes in the vial. From this base solution 1 ml syringes with solutions for injection (A, B, C & D) were prepared by dilution with isotonic saline for injection purposes (details are described in the protocol). - Solution A: 0,1 ml 2,5 mg/ml ICG injected intradermally in the dorsum of the right hand (depot A). - Solution B: 0,1 ml 1,0 mg/ml ICG injected intradermally in the dorsum of the left hand (depot B). - Solution C: 0,3 ml 0,83 mg/ml ICG injected intradermally in the dorsum of the right foot (depot C). - Solution D: 0,1 ml 2,5 mg/ml ICG injected subcutanously in the dorsum of the left foot (depot D).

Number of subjects in period 1	Group A
Started	19
Completed	18
Not completed	1
Adverse event, non-fatal	1

Baseline characteristics

Top of page

Reporting group title

Overall trail

Reporting group description

Group A consisting of healthy adult volunteers recruited evenly from both genders (see Subject disposition, Period 1). The reporting groups comprise data collceted from the same subjects (group A, 1 excluded, see non-serious adverse events).

Reporting group values	Overall trail	Total
Number of subjects	19	19
Age categorical
Being adult (age 18 - 64 years) was an inclusion criterion; however effect of age was not a factor under investigation as such. During recruitment, an even age dispersion in the adult age range was sought for both genders, but not treated as a recruitment criterion per se. Volunteering subjects were primarily young (< 30 years) in both genders as reflected in the final study population age median.
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	19	19
From 65-84 years	0	0
85 years and over	0	0
Age continuous
Being adult (age 18 - 64 years) was an inclusion criterion; however effect of age was not a factor under investigation as such. During recruitment, an even age dispersion in the adult age range was sought for both genders, but not treated as a recruitment criterion per se. Volunteering subjects were primarily young (< 30 years) in both genders as reflected in the final study population age median.
Units: years
median (full range (min-max))	24 (18 to 59)	-
Gender categorical
An even gender distribution was sought during recruitment. One female subject was excluded due to unintended intravenous injection rendering the video unusable for later analysis (See non-serious adverse events).
Units: Subjects
Female	11	11
Male	8	8

Subject analysis set title

Video analysis results

Subject analysis set type

Full analysis

Subject analysis set description

Results of visual and semi-automatic analysis of near infrared fluorescence videos recorded in group A except for one excluded subject (see non-serious adverse events). Results from each video are: (1) Mean package count (explained in “end points”), (2) maximum package count and (3) numbers of visualised lymphatic collectors.

Subject analysis set title

Age by gender

Subject analysis set type

Sub-group analysis

Subject analysis set description

Age distribution in male and female subjects, who completed the protocol.

Subject analysis sets values	Video analysis results	Age by gender
Number of subjects	18	18
Age categorical
Being adult (age 18 - 64 years) was an inclusion criterion; however effect of age was not a factor under investigation as such. During recruitment, an even age dispersion in the adult age range was sought for both genders, but not treated as a recruitment criterion per se. Volunteering subjects were primarily young (< 30 years) in both genders as reflected in the final study population age median.
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	18	18
From 65-84 years	0	0
85 years and over	0	0
Age continuous
Being adult (age 18 - 64 years) was an inclusion criterion; however effect of age was not a factor under investigation as such. During recruitment, an even age dispersion in the adult age range was sought for both genders, but not treated as a recruitment criterion per se. Volunteering subjects were primarily young (< 30 years) in both genders as reflected in the final study population age median.
Units: years
median (full range (min-max))	24 (18 to 59)	24 (18 to 59)
Gender categorical
An even gender distribution was sought during recruitment. One female subject was excluded due to unintended intravenous injection rendering the video unusable for later analysis (See non-serious adverse events).
Units: Subjects
Female	10	10
Male	8	8

End points

Top of page

Reporting group title

Group A

Reporting group description

Subject analysis set title

Video analysis results

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Age by gender

Subject analysis set type

Sub-group analysis

Subject analysis set description

Age distribution in male and female subjects, who completed the protocol.

Primary: Mean number of packages in 30 min

Top of page

End point title

Mean number of packages in 30 min

End point description

In each subject 8 videos were recorded of pumping activity in lymphatic collectors draining 4 depots injected dorsally and interdigitally in both hands and - feet with methodological variations and time delay as specified below. Pumping activity was quantified as spike-like fluorescence signal intensity increases recorded in 3 regions of interest (ROI) placed over each visualised collector enabling semi-automatic counting of package numbers in a 30 min recording. Mean package number is the average count from all ROIs in a video. As the number of visualised collectors varies, the number of ROIs also varies. Depot A: 0,1 ml 2,5 mg/ml ICG-PULSION(R), i.d., right hand. Depot B: 0,1 ml 1,0 mg/ml ICG-PULSION(R), i.d., left hand. Depot C: 0,3 ml 0,83 mg/ml ICG-PULSION(R), i.d., right foot. Depot D: 0,1 ml 2,5 mg/ml ICG-PULSION(R), s.c., left foot. Time delays from depot injection to recording were 0, 30 & 150 min for depot A, 30 min for depot B & 30 & 120 min for depot C and D.

End point type

Primary

End point timeframe

Analysis results of videos recorded during study visits from 30.12.2014 to 30.05.2017.

End point values	Group A	Video analysis results
Number of subjects analysed	18 ^[1]	18
Units: Package count in 30 min
median (full range (min-max))
Depot A 0 min	11 (3 to 42)	11 (0 to 42)
Depot A 30 min	14 (1 to 34)	14 (1 to 34)
Depot A 150 min	11 (2 to 38)	11 (2 to 38)
Depot B 30 min	11 (5 to 37)	11 (5 to 37)
Depot C 30 min	8 (1 to 24)	8 (1 to 24)
Depot C 120 min	12 (2 to 30)	12 (2 to 30)
Depot D 30 min	9 (0 to 35)	9 (0 to 35)
Depot D 120 min	12 (4 to 29)	12 (4 to 29)

Attachments

GLMM mean package count

Notes
[1] - xx

GLMM mean "package" count

Statistical analysis description

No power calculation was performed, since insufficient human data existed in the literature. The study was exploratory in nature aiming at identifying large systematic differences; the null hypothesis being no difference in lymphatic collector pumping activity between described method variations (time delay, injection technique, ICG solution concentration, injected volume) or dependence on extremity (hands vs. feet), gender or age.

Comparison groups

Group A v Video analysis results

Number of subjects included in analysis

Analysis specification

Post-hoc

Analysis type

equivalence ^[2]

P-value

= 0.02 ^[3]

Method

Mixed models analysis

Parameter type

Estimated marginal means

Point estimate

12.4

Confidence interval

level

95%

sides

2-sided

lower limit

10.1

upper limit

15.1

Variability estimate

Standard error of the mean

Dispersion value

1.2

Notes
[2] - Data was best fitted to a gamma probability distributiondistribution (Log link function). Information criterion: Akaike corrected 302,179 The model adjusted for multiple comparisons. The target was "mean package count". Fixed effects were: Gender, extremity, injection (subcutaneous vs intradermal), concentration, time delay and age. Subject ID was treated as a random effect.
[3] - Intercept: p<0,00 Gender: p=0,02, Table 1 & Figure 1 No significant effect of extremity (p=0,21), injection (p=0,69), concentration (p=0,65), time delay (p=0,39) or age (p=0,29) Residual effect: Estimate 0,34, p < 0,00. Random effect: p = 0,09

Secondary: Maximum number of packages in 30 min

Top of page

End point title

Maximum number of packages in 30 min

End point description

In each subject 8 videos were recorded of pumping activity in lymphatic collectors draining 4 depots injected dorsally and interdigitally in both hands and - feet with methodological variations and time delay as specified below. Pumping activity was quantified as spike-like fluorescence signal intensity increases recorded in 3 regions of interest (ROI) placed over each visualised collector enabling semi-automatic counting of package numbers in a 30 min recording. Maximum package number is the highest count found in any ROI in a video. As the number of visualised collectors varies, the number of ROIs also varies. Depot A: 0,1 ml 2,5 mg/ml ICG-PULSION(R), i.d., right hand. Depot B: 0,1 ml 1,0 mg/ml ICG-PULSION(R), i.d., left hand. Depot C: 0,3 ml 0,83 mg/ml ICG-PULSION(R), i.d., right foot. Depot D: 0,1 ml 2,5 mg/ml ICG-PULSION(R), s.c., left foot. Time delays from depot injection to recording were 0, 30 & 150 min for depot A, 30 min for depot B & 30 & 120 min for depot C and D

End point type

Secondary

End point timeframe

Analysis results of videos recorded during study visits from 30.12.2014 to 30.05.2017.

End point values	Group A	Video analysis results
Number of subjects analysed	18	18
Units: Frequency (package count/30 min)
median (full range (min-max))
A 0 min	16 (3 to 54)	16 (3 to 54)
A 30 min	23 (1 to 77)	23 (1 to 77)
A 150 min	14 (3 to 56)	14 (3 to 56)
B 30 min	15 (6 to 68)	15 (6 to 68)
C 30 min	10 (2 to 47)	10 (2 to 47)
C 120 min	17 (4 to 59)	17 (4 to 59)
D 30 min	14 (0 to 56)	14 (0 to 56)
D 120 min	20 (6 to 40)	20 (6 to 40)

Attachments

GLMM max package count

GLMM maximum "package" count

Statistical analysis description

Comparison groups

Group A v Video analysis results

Number of subjects included in analysis

Analysis specification

Post-hoc

Analysis type

equivalence ^[4]

P-value

= 0.02 ^[5]

Method

Mixed models analysis

Parameter type

Grand Mean Estimate

Point estimate

18.2

Confidence interval

level

95%

sides

2-sided

lower limit

14.5

upper limit

22.9

Variability estimate

Standard error of the mean

Dispersion value

2.06

Notes
[4] - Data was best fitted to a gamma probability distributiondistribution (Log link function). Information criterion: Akaike corrected 332,890 The model adjusted for multiple comparisons. The target was "maximum package count". Fixed effects were: Gender, extremity, injection (subcutaneous vs intradermal), concentration, time delay and age. Subject ID was treated as a random effect.
[5] - Intercept (p<0,00) Gender: p = 0,02, Table 2 & Figure 2 No significant effect of extremity (p=0,42), injection (p=0,80), concentration (p=0,48), time delay (p=0,47) & age (p=0,31) Residual effect: Estimate 0.42, p < 0,00. Random effect: p = 0,07

Secondary: Number of lymphatic collectors by depot type and delay

Top of page

End point title

Number of lymphatic collectors by depot type and delay

End point description

In each subject 8 videos were recorded of pumping activity in lymphatic collectors draining 4 depots injected dorsally and interdigitally in both hands and - feet with methodological variations and time delay as specified below. The number of lymphatic collectors visualised in the beginning of each video was counted by visual assessment. Depot A: 0,1 ml 2,5 mg/ml ICG-PULSION(R), i.d., right hand. Depot B: 0,1 ml 1,0 mg/ml ICG-PULSION(R), i.d., left hand. Depot C: 0,3 ml 0,83 mg/ml ICG-PULSION(R), i.d., right foot. Depot D: 0,1 ml 2,5 mg/ml ICG-PULSION(R), s.c., left foot. Time delays from depot injection to recording were 0, 30 & 150 min for depot A, 30 min for depot B & 30 & 120 min for depot C and D.

End point type

Secondary

End point timeframe

Analysis results of videos recorded during study visits from 30.12.2014 to 30.05.2017.

End point values	Group A	Video analysis results
Number of subjects analysed	18	18
Units: Count
median (full range (min-max))
A 0 min	2 (1 to 3)	2 (1 to 3)
A 30 min	3 (1 to 4)	3 (1 to 4)
A 150 min	4 (1 to 8)	4 (1 to 8)
B 30 min	2 (1 to 3)	2 (1 to 3)
C 30 min	3 (1 to 5)	3 (1 to 5)
C 120 min	3 (1 to 5)	3 (1 to 5)
D 30 min	2 (1 to 5)	2 (1 to 5)
D 120 min	2 (1 to 4)	2 (1 to 4)

Attachments

Numbers of collectors by delay

Number of visualised lymphatic collectors

Statistical analysis description

No power calculation was performed, since insufficient human data existed in the literature. The study was exploratory in nature aiming at identifying large systematic differences; the null hypothesis being no difference in number of lymphatic collectors between depot ID (defining extremity, injection technique, ICG solution concentration and injected volume), time delay, gender and age.

Comparison groups

Group A v Video analysis results

Number of subjects included in analysis

Analysis specification

Post-hoc

Analysis type

equivalence ^[6]

P-value

= 0.02 ^[7]

Method

Mixed models analysis

Parameter type

Grand Mean Estimate

Point estimate

2.4

Confidence interval

level

95%

sides

2-sided

lower limit

2.1

upper limit

2.8

Variability estimate

Standard error of the mean

Dispersion value

0.2

Notes
[6] - The target distribution was Loglinear. Information criterion: Akaike corrected 227,398 The model adjusted for multiple comparisons. The target was "number of lymphatic collectors". Fixed effects were: Gender, age, depot ID (A, B, C & D) and time delay (min). Subject ID was a random effect
[7] - Intercept: p=0.03 Delay: p=0.02 (coefficient 0.002 95% CI 0.00 - 0.004) No significant effect of gender (p=0.47), age (p=0.50) or depot: p>0.05 (see box-plot) Random effect: p=0.42

Secondary: Age by gender

Top of page

End point title

Age by gender

End point description

Age distribution by gender in group A.

End point type

Secondary

End point timeframe

Analysis results from subjects recruited from 30.12.2014 to 30.05.2017.

End point values	Group A
Number of subjects analysed	18
Units: Years
median (full range (min-max))
Males	25 (18 to 59)
Females	24 (19 to 46)

Attachments

Age by gender

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

30-12-2017 to 06-06-2017

Adverse event reporting additional description

Clinical observation of possible acute local or systemic SAR during the study visit from injection of the first depot to completion of video recordings. Instruction to phone primary investigator in case of suspected delayed AE or AR. Mandatory phone interview by subinvestigator 1 week after the study visit to confirm no occurrence of AE or AR

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

Group A

Reporting group description

All healthy adult volunteers that were included in the study.

Serious adverse events	Group A
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 19 (0.00%)
number of deaths (all causes)	0
number of deaths resulting from adverse events	0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Group A
Total subjects affected by non serious adverse events
subjects affected / exposed	1 / 19 (5.26%)
Investigations
Unintended intravenous injection
Additional description: In one female subject, injection af depot A (see Subject disposition, Group A) was unintendedly injected intravenously instead of the planned intradermal injection. This did not result in any adverse reactions (neither acute nor delayed).
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

08 Jul 2016

Increase in the allowed total number of subjects to be recruited to a maximum of 40 if deemed necessary. The amendment enabled replacement of subjects with an incomplete dataset or a dataset that could not be analysed due to reduced technical quality ensuring sufficient data for a comprehensible analysis of overall trial results.

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
06 Jun 2017	The last subject completed participation on 06-jun-2017. After, the interim analysis period started and until 04-03-2019 it was still our intend to complete the trial as described in the protocol. However, due to lack of personnel resources to complete the remaining study visits and following data analysis Sponsor and Investigator agreed to terminate the study before inititation of group B. This lack of personnel resources developed due to a combination of changes in employee composition and increasing clinical work load, and was not likely to improve in the foreseeable future. No adverse reactions occurred in the trial period; however, due to the small number of study subjects examined, rare adverse reactions are not likely to occur in this material. Overall the present data do not have a negative effect on the overall risk benefit assessment.	-

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

The study population is relatively small increasing the risk of type 2 errors i.e. not finding small but significant effects of applied method variations, time delay, extremity and age. Studies with larger populations are needed to elucidate this.

http://www.ncbi.nlm.nih.gov/pubmed/22924087
http://www.ncbi.nlm.nih.gov/pubmed/26993717
http://www.ncbi.nlm.nih.gov/pubmed/22808440

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Clinical trials

Clinical Trial Results:
Near infrared imaging and measurement of extremity lymphatic collector function using indocyanine green

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Mean number of packages in 30 min

Primary: Mean number of packages in 30 min

Secondary: Maximum number of packages in 30 min

Secondary: Maximum number of packages in 30 min

Secondary: Number of lymphatic collectors by depot type and delay

Secondary: Number of lymphatic collectors by depot type and delay

Secondary: Age by gender

Secondary: Age by gender

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: Near infrared imaging and measurement of extremity lymphatic collector function using indocyanine green

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Mean number of packages in 30 min

Primary: Mean number of packages in 30 min

Secondary: Maximum number of packages in 30 min

Secondary: Maximum number of packages in 30 min

Secondary: Number of lymphatic collectors by depot type and delay

Secondary: Number of lymphatic collectors by depot type and delay

Secondary: Age by gender

Secondary: Age by gender

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Clinical Trial Results:
Near infrared imaging and measurement of extremity lymphatic collector function using indocyanine green