E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers |
Raske forsøgspersoner |
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E.1.1.1 | Medical condition in easily understood language |
Healthy volunteers |
Raske forsøgspersoner |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10022891 |
E.1.2 | Term | Investigations |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess normal anatomy and dynamics of pumping activity in extremity lymphatic collectors with near infrared fluorescence imaging
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At vurdere normal anatomi og pumpeaktivitetsdynamik i ekstremitetslymfekar med nær infrarød fluorescens billeddannelse
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E.2.2 | Secondary objectives of the trial |
To measure the effect of specific factors in method and physical perturbations on extremity lymphatic pumping activity
Method factors: (1) Time from depot injection to imaging, (2) ICG concentration, (3) Injected volume, (4) Level of injection - s.c. vs. i.d.
Physical perturbations: (1) Skin heating, (2) Depot dependency, (3) Exercise, (4) Solution tonicity.
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At måle effekten af specifikke metodefaktorer og fysiske perturbationer på pumpeaktiviteten i ekstremitetslymfekar.
Metodefaktorer: (1) Tid fra depot-injektion til billeddannelse, (2) ICG koncentration, (3) Injiceret volumen, (4) Dybden af injektionen - s.c. vs. i.d..
Fysiske perturbationer: (1) Hudopvarmning, (2) Depot sænket under hjerteniveau, (3) Fysisk aktivitet, (4) Opløsningens tonicitet.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Healthy. 2. Capable. 3. Age 18-65 years. 4. Normal BMI range (18-25 kg/m2 ).
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1. Rask. 2. Myndig. 3. Alder 18-65 år. 4. Normalt Body Mass Index (BMI 18-25 kg/m2)
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E.4 | Principal exclusion criteria |
1. Any known disease. 2. Any chronic medication. 3. Pregnancy or lactation. A negative urine-HCG pregnancy test on the day of participation is mandatory for fertile women subjects. 4. Contraindications to the use of ICG-PULSION® as specified in the Summary of Product Characteristics provided by the manufacturer (Pulsion Medical Systems AG) 5. Smoking or other nicotine chronic use. 6. Clinical signs of oedema (pitting, swelling), venous insufficiency (pigmentation, dermatosclerosis, wounds) or local inflammation (erythema, swelling, warm skin).
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Kendt sygdom. 2. Fast medicin. 3. Graviditet eller amning. En negativ graviditetstest (urin-HCG) på forsøgsdagen er påkrævet for fertile kvinder. 4. Kontraindikationer mod brugen af ICG i henhold til producentens produktresume (Pulsion Medical Systems AG). 5. Rygning eller andet fast nikotinforbrug. 6. Kliniske fund forenelige med ødem (pitting, hævelse), kronisk venesygdom (pigmentering, dermatosklerose, sår) eller lokal inflammation (rødme, hævelse, varme).
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E.5 End points |
E.5.1 | Primary end point(s) |
Anatomy and pumping activity of extremity lymphatic collectors. |
Anatomi og pumpeaktivitet i ekstremitetslymfekar.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
When 10 subjects in each group with complete data sets have participated according to protocol and the technical result (video quality) is acceptable (analysable). If a data set from a subject is rejected due to poor technical result, a matched substitute subject is recruited. The maximum total number of subjects in the trial is 40.
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Når 10 forsøgspersoner i hver gruppe har gennemført forsøget i henhold til protokollen med et komplet datasæt, som er teknisk tilfredsstillende (videokvalitet) og analyserbart. Hvis en forsøgspersons datasæt forkastes pga. teknisk utilfredsstillende resultat (analyse af video upålidelig), vil en matchet erstatningsforsøgsperson blive rekrutteret. Dog vil det maksimale totale antal forsøgspersoner være 40. |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Analytical - normal variation and method development. |
Analytisk - normalvariation og metodeudvikling. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |