Trial Outcomes & Findings for Efficacy of Adhesive Strength of New Hydrogel Formulation (NCT NCT04309110)
NCT ID: NCT04309110
Last Updated: 2024-02-23
Results Overview
Self reported - how well did the geko™ device stick to the patients leg? Scale 1-5, Lowest score indicates best adhesion.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
10 days
Results posted on
2024-02-23
Participant Flow
Participant milestones
| Measure |
Geko™ T3 Device
Current geko™ device incorporating hydrogel adhesive designated KM10T
|
Geko™ X-T3 Device
Next generation geko™ device incorporating new hydrogel adhesive designated KM40C
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Geko™ T3 Device
n=20 Participants
Current geko™ device incorporating hydrogel adhesive designated KM10T
|
Geko™ X-T3 Device
n=20 Participants
Next generation geko™ device incorporating new hydrogel adhesive designated KM40C
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
41-50
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Age, Customized
51-60
|
4 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Age, Customized
61-70
|
4 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Age, Customized
71-80
|
7 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
|
Age, Customized
>81
|
5 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
20 participants
n=20 Participants
|
20 participants
n=20 Participants
|
40 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 10 daysSelf reported - how well did the geko™ device stick to the patients leg? Scale 1-5, Lowest score indicates best adhesion.
Outcome measures
| Measure |
Geko™ T3 Device
n=20 Participants
Current geko™ device incorporating hydrogel adhesive designated KM10T
|
Geko™ X-T3 Device
n=20 Participants
Next generation geko™ device incorporating new hydrogel adhesive designated KM40C
|
|---|---|---|
|
Efficacy of the Skin Adhesive Strength of Hydrogel KM40C Compared to That of Hydrogel KM10T.
|
1.52 score on a scale
Standard Error 0.10
|
1.23 score on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: 10 daysReporting of the incidence of adverse events , incidence of serious adverse events, incidence of study treatment related adverse events, and the incidence of device related adverse events
Outcome measures
Outcome data not reported
Adverse Events
Geko™ T3 Device
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Geko™ X-T3 Device
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Geko™ T3 Device
n=20 participants at risk
Current geko™ device incorporating hydrogel adhesive designated KM10T
|
Geko™ X-T3 Device
n=20 participants at risk
Next generation geko™ device incorporating new hydrogel adhesive designated KM40C
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash at site of geko™ device application
|
5.0%
1/20 • Number of events 1 • Maximum of 10 days from trial inclusion
|
5.0%
1/20 • Number of events 1 • Maximum of 10 days from trial inclusion
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place