Trial Outcomes & Findings for Safety and Effectiveness Clinical Evaluation of Injectable Medical Devices (NCT NCT06142578)
NCT ID: NCT06142578
Last Updated: 2025-04-25
Results Overview
Primary endpoint was the proportion of subjects having an improvement of the zone treated with the overall FILLGEL range of devices, in all the indications, as assessed by the independent investigator, one month after treatment, using the Global Aesthetic Improvement Scale (GAIS) (subjects with a GAIS "improved", "much improved" or "very much improved"). This proportion of responders was compared to a theoretical proportion of 50%.
COMPLETED
NA
68 participants
1 month
2025-04-25
Participant Flow
Participant milestones
| Measure |
Group 1
FILLGEL 0
|
Group 2
FILLGEL 1
|
Group 3
FILLGEL 2
|
Group 4
FILLGEL 3
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
17
|
17
|
|
Overall Study
COMPLETED
|
17
|
17
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
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 |
Group 1
n=17 Participants
FILLGEL 0
|
Group 2
n=17 Participants
FILLGEL 1
|
Group 3
n=17 Participants
FILLGEL 2
|
Group 4
n=17 Participants
FILLGEL 3
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=68 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=17 Participants
|
17 Participants
n=17 Participants
|
17 Participants
n=17 Participants
|
17 Participants
n=17 Participants
|
68 Participants
n=68 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=68 Participants
|
|
Age, Continuous
|
57.7 years
n=17 Participants
|
46.7 years
n=17 Participants
|
56.1 years
n=17 Participants
|
54.1 years
n=17 Participants
|
53.6 years
n=68 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=17 Participants
|
15 Participants
n=17 Participants
|
15 Participants
n=17 Participants
|
17 Participants
n=17 Participants
|
64 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=17 Participants
|
2 Participants
n=17 Participants
|
2 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
4 Participants
n=68 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
17 participants
n=17 Participants
|
17 participants
n=17 Participants
|
17 participants
n=17 Participants
|
17 participants
n=17 Participants
|
68 participants
n=68 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: This results is not reported per arm. It is the very purpose of the primary endpoint, to assess the performance of the overall FILLGEL range, independantly of the Arms/groups. The results were not expressed by arms/groups separately, but for the overall FILLGEL range only, as explained in the description: Primary endpoint was the proportion of subjects having an improvement of the zone treated with the overall FILLGEL range of devices, in all the indications...
Primary endpoint was the proportion of subjects having an improvement of the zone treated with the overall FILLGEL range of devices, in all the indications, as assessed by the independent investigator, one month after treatment, using the Global Aesthetic Improvement Scale (GAIS) (subjects with a GAIS "improved", "much improved" or "very much improved"). This proportion of responders was compared to a theoretical proportion of 50%.
Outcome measures
| Measure |
All Groups
n=68 Participants
FILLGEL 0,1,2,3
|
Group 1
FILLGEL 0
|
Group 2
FILLGEL 1
|
Group 3
FILLGEL 2
|
Group 4
FILLGEL 3
|
|---|---|---|---|---|---|
|
Performance
|
97.6 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 months, 12 monthsProportion of responders (subjects with a GAIS "improved", "much improved" and "very much improved") for the whole FILLGEL range and by device/indication, with the statistical comparison to the theoretical proportion of 50%.
Outcome measures
| Measure |
All Groups
n=68 Participants
FILLGEL 0,1,2,3
|
Group 1
n=17 Participants
FILLGEL 0
|
Group 2
n=17 Participants
FILLGEL 1
|
Group 3
n=17 Participants
FILLGEL 2
|
Group 4
n=17 Participants
FILLGEL 3
|
|---|---|---|---|---|---|
|
Performance - GAIS Investigator
At 6 months
|
94 percentage of participants
|
82.4 percentage of participants
|
95.6 percentage of participants
|
100 percentage of participants
|
96.4 percentage of participants
|
|
Performance - GAIS Investigator
At 12 months
|
88 percentage of participants
|
76.5 percentage of participants
|
95.6 percentage of participants
|
94.1 percentage of participants
|
86.8 percentage of participants
|
SECONDARY outcome
Timeframe: Immediatly after injection (D0), 1 month, 6 months, 12 monthsProportion of subjects presenting at least one Injection Site Reaction (ISR) evaluated by the investigator, by visit and by indication.
Outcome measures
| Measure |
All Groups
n=17 Participants
FILLGEL 0,1,2,3
|
Group 1
n=17 Participants
FILLGEL 0
|
Group 2
n=17 Participants
FILLGEL 1
|
Group 3
n=17 Participants
FILLGEL 2
|
Group 4
FILLGEL 3
|
|---|---|---|---|---|---|
|
Patients Safety
Immediatly after injection (D0)
|
88 percentage of at least 1 sign of ISR
|
100 percentage of at least 1 sign of ISR
|
47 percentage of at least 1 sign of ISR
|
47 percentage of at least 1 sign of ISR
|
—
|
|
Patients Safety
1 month
|
24 percentage of at least 1 sign of ISR
|
13 percentage of at least 1 sign of ISR
|
6 percentage of at least 1 sign of ISR
|
6 percentage of at least 1 sign of ISR
|
—
|
|
Patients Safety
6 months
|
0 percentage of at least 1 sign of ISR
|
13 percentage of at least 1 sign of ISR
|
0 percentage of at least 1 sign of ISR
|
0 percentage of at least 1 sign of ISR
|
—
|
|
Patients Safety
12 months
|
6 percentage of at least 1 sign of ISR
|
0 percentage of at least 1 sign of ISR
|
0 percentage of at least 1 sign of ISR
|
0 percentage of at least 1 sign of ISR
|
—
|
SECONDARY outcome
Timeframe: 1, 6, 12 monthsProportion of responders (subjects with a GAIS="improved", "much improved" and "very much improved") for the whole FILLGEL range and by device/indication, with the statistical comparison to the theoretical proportion of 50%.
Outcome measures
| Measure |
All Groups
n=68 Participants
FILLGEL 0,1,2,3
|
Group 1
n=17 Participants
FILLGEL 0
|
Group 2
n=17 Participants
FILLGEL 1
|
Group 3
n=17 Participants
FILLGEL 2
|
Group 4
n=17 Participants
FILLGEL 3
|
|---|---|---|---|---|---|
|
Subject Satisfaction - GAIS Subject
At 1 month
|
90.4 percentage of participants
|
94.1 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
75.3 percentage of participants
|
|
Subject Satisfaction - GAIS Subject
At 6 months
|
81.9 percentage of participants
|
64.7 percentage of participants
|
92.9 percentage of participants
|
88.2 percentage of participants
|
81.2 percentage of participants
|
|
Subject Satisfaction - GAIS Subject
At 12 months
|
79.5 percentage of participants
|
76.4 percentage of participants
|
92.9 percentage of participants
|
88.1 percentage of participants
|
63.3 percentage of participants
|
SECONDARY outcome
Timeframe: After injectionDistribution of each item of the questionnaire answered by the injectors (injector's satisfaction on the injection quality using subjective evaluation questionnaire). The scale is "Very dissatisfied", "Dissatisfied", "Neither satisfied nor dissatisfied", "Satisfied" or "Very satisfied" The percentage of satisfied injectors includes participants that reported being "satisfied" and "very satisfied"
Outcome measures
| Measure |
All Groups
n=17 Participants
FILLGEL 0,1,2,3
|
Group 1
n=17 Participants
FILLGEL 0
|
Group 2
n=17 Participants
FILLGEL 1
|
Group 3
n=17 Participants
FILLGEL 2
|
Group 4
FILLGEL 3
|
|---|---|---|---|---|---|
|
Injector Satisfaction
Easiness of injection
|
100 percentage of satisfied injectors
|
100 percentage of satisfied injectors
|
100 percentage of satisfied injectors
|
100 percentage of satisfied injectors
|
—
|
|
Injector Satisfaction
Easiness of product positionning
|
100 percentage of satisfied injectors
|
100 percentage of satisfied injectors
|
100 percentage of satisfied injectors
|
100 percentage of satisfied injectors
|
—
|
|
Injector Satisfaction
Immediate results
|
100 percentage of satisfied injectors
|
100 percentage of satisfied injectors
|
100 percentage of satisfied injectors
|
100 percentage of satisfied injectors
|
—
|
|
Injector Satisfaction
Result after massage
|
100 percentage of satisfied injectors
|
100 percentage of satisfied injectors
|
100 percentage of satisfied injectors
|
100 percentage of satisfied injectors
|
—
|
Adverse Events
Device Under Investigation (Total of Groups)
Group 1
Group 2
Group 3
Group 4
Serious adverse events
| Measure |
Device Under Investigation (Total of Groups)
n=68 participants at risk
All the groups Group 1: FILLGEL 0 Group 2: FILLGEL 1 Group 3: FILLGEL 2 Group 4: FILLGEL 3
|
Group 1
n=17 participants at risk
FILLGEL 0
|
Group 2
n=17 participants at risk
FILLGEL 1
|
Group 3
n=17 participants at risk
FILLGEL 2
|
Group 4
n=17 participants at risk
FILLGEL 3
|
|---|---|---|---|---|---|
|
General disorders
spleen cyst
|
1.5%
1/68 • Number of events 1 • 12 months
|
0.00%
0/17 • 12 months
|
5.9%
1/17 • Number of events 1 • 12 months
|
0.00%
0/17 • 12 months
|
0.00%
0/17 • 12 months
|
|
General disorders
strangulated femoral hernia
|
1.5%
1/68 • Number of events 1 • 12 months
|
5.9%
1/17 • Number of events 1 • 12 months
|
0.00%
0/17 • 12 months
|
0.00%
0/17 • 12 months
|
0.00%
0/17 • 12 months
|
Other adverse events
| Measure |
Device Under Investigation (Total of Groups)
n=68 participants at risk
All the groups Group 1: FILLGEL 0 Group 2: FILLGEL 1 Group 3: FILLGEL 2 Group 4: FILLGEL 3
|
Group 1
n=17 participants at risk
FILLGEL 0
|
Group 2
n=17 participants at risk
FILLGEL 1
|
Group 3
n=17 participants at risk
FILLGEL 2
|
Group 4
n=17 participants at risk
FILLGEL 3
|
|---|---|---|---|---|---|
|
Surgical and medical procedures
ADE
|
13.2%
9/68 • Number of events 12 • 12 months
|
23.5%
4/17 • Number of events 5 • 12 months
|
11.8%
2/17 • Number of events 2 • 12 months
|
5.9%
1/17 • Number of events 2 • 12 months
|
11.8%
2/17 • Number of events 3 • 12 months
|
|
Surgical and medical procedures
AE not device related
|
41.2%
28/68 • Number of events 79 • 12 months
|
17.6%
3/17 • Number of events 13 • 12 months
|
52.9%
9/17 • Number of events 31 • 12 months
|
47.1%
8/17 • Number of events 11 • 12 months
|
47.1%
8/17 • Number of events 24 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER