Clinical Trial Results:
Evaluation of the SONAS® ultrasound device for the assessment of bilateral cerebral perfusion in subjects with acute stroke
|
Summary
|
|
EudraCT number |
2018-001279-19 |
Trial protocol |
DE AT |
Global end of trial date |
29 Dec 2019
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
25 Dec 2021
|
First version publication date |
25 Dec 2021
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
SONAS2018
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
BURL Concepts, Inc.
|
||
Sponsor organisation address |
4901 Morena Blvd, suite 703, San Diego, CA 92117, United States,
|
||
Public contact |
Clinical Trials Information, BURL Concepts, Inc., 001 619277 3702,
|
||
Scientific contact |
Clinical Trials Information, BURL Concepts, Inc., 001 619277 3702,
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
20 Feb 2020
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
29 Dec 2019
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
To determine the safety and feasibility of detecting acoustic signals related to blood supply in subjects with acute stroke by using the SONAS® device.
|
||
Protection of trial subjects |
The clinical investigation was conducted in compliance with the Declaration of Helsinki, clinical investigation plan, EN ISO 14155:2011, ICH GCP, and any conditions of approval imposed by the reviewing ethics committee, competent authority and/or local institution.
Only subjects with acute stroke meeting all inclusion criteria and none of the exclusion criteria had to be entered in the clinical investigation. All subjects were free to withdraw at any time and for any reasons.
Subjects underwent SONAS® testing only after receiving routine clinical care for stroke management (including cerebral imaging computed tomography [cCT] or cerebral magnetic resonance imaging [cMRI]). All subjects were carefully monitored for the occurrence of adverse events (AEs) from the start of any investigation-related procedure until 72 hours after the second SONAS® testing.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jan 2019
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Germany: 20
|
||
Worldwide total number of subjects |
20
|
||
EEA total number of subjects |
20
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
7
|
||
From 65 to 84 years |
10
|
||
85 years and over |
3
|
||
|
|||||||||||||
|
Recruitment
|
|||||||||||||
Recruitment details |
Male and female subjects aged at least 18 years with acute stroke diagnosed within 24 hours of symptoms onset and assessed intracranial arteria circulation by cMRI or cCCT were recruited in 1 center in Germany. The first subject signed the informed consent form on 01-Apr-2019 and the last subject on 25-Dec-2019. | ||||||||||||
|
Pre-assignment
|
|||||||||||||
Screening details |
20 subjects signed the informed consent. The SONAS® test was performed at least once on all subjects using the SONAS® device. | ||||||||||||
|
Period 1
|
|||||||||||||
Period 1 title |
Overall investigation (overall period)
|
||||||||||||
Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
|
||||||||||||
Blinding used |
Not blinded | ||||||||||||
|
Arms
|
|||||||||||||
|
Arm title
|
SONAS® test | ||||||||||||
Arm description |
Subjects with 2 SONAS® tests using the SONAS® device 24 (±4) hours apart. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
SONAS® device
|
||||||||||||
Investigational medicinal product code |
|||||||||||||
Other name |
|||||||||||||
Pharmaceutical forms |
Pharmaceutical dose form not applicable
|
||||||||||||
Routes of administration |
External use
|
||||||||||||
Dosage and administration details |
2 SONAS® tests using the SONAS® device were performed 24 (±4) hours apart.
|
||||||||||||
|
|||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
SONAS® test
|
|||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects with 2 SONAS® tests using the SONAS® device 24 (±4) hours apart. | |||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
SONAS® test
|
||
Reporting group description |
Subjects with 2 SONAS® tests using the SONAS® device 24 (±4) hours apart. | ||
|
|||||||||||||||
End point title |
Diagnostic performance results of SONAS® at first assessment [1] | ||||||||||||||
End point description |
The endpoint consists of the following parameters:
• Diagnostic accuracy: percentage of subjects in whom the SONAS® assessment result matched the reference standard assessment
• Sensitivity: percentage of subjects positive per SONAS®, among those subjects with confirmed strokes per the reference standard
• Specificity: percentage of subjects negative per SONAS®, among those subjects confirmed as not having a stroke per the reference standard
|
||||||||||||||
End point type |
Primary
|
||||||||||||||
End point timeframe |
At Day 0 (first SONAS® test).
|
||||||||||||||
| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis for this end point was done. |
|||||||||||||||
|
|||||||||||||||
| Notes [2] - 3 subjects were excluded from analysis: N=1 met an exclusion criterion, N=2 had no usable data. |
|||||||||||||||
| No statistical analyses for this end point | |||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
From the start of any investigation-related procedure until 72 hours after the second SONAS® testing.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
22.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
SONAS® test
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
10 Jul 2019 |
Changes to version 3.0 (26-Nov-2018):
- All components and subcomponents of the SONAS® system according to the investigator’s brochure were described.
- Software version 1.12 was to be used for the SONAS® operating unit.
- Inclusion criterion no. 3 was adapted. The required NIHSS score was reduced from ≥10 to ≥6, because neurological deficits may develop in a delayed manner, i.e. symptoms may be mild at admission despite a later proven vascular occlusion.
- The targeted study population was extended from “subjects with acute large vessel occlusion stroke” to “subjects with acute stroke”, because in some subjects with severe neurological deficits, vascular occlusion cannot be proven anymore at admission (e.g. due to spontaneous recanalization). The requirement for a confirmed occlusion was removed in inclusion criterion no. 5.
- If an MRI or CT is performed as part of the routine clinical practice at 24 hours, images were to be collected.
- It was clarified that one SONAS® application may include a repeat test immediately after the first test to improve the data analysis if it does not jeopardize the subject's health according to the investigator’s judgement.
- If the subject was able to give consent but was unable to sign the consent form in person due to a physical disability, the subject's willingness to participate in the study may be confirmed by a witness. |
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
