Trial Outcomes & Findings for Feasibility Study of the TruSculpt Radiofrequency Device (NCT NCT03018587)
NCT ID: NCT03018587
Last Updated: 2023-03-07
Results Overview
Degree of improvement in the treatment area at 12 weeks post-treatment compared with Baseline photo as assessed by the Investigator using Global Aesthetic Improvement Scale(GAIS): 4 = Very Significant Improvement (\>75%), 3 = Significant Improvement (51 - 75%), 2 = Moderate Improvement (26 - 50%), 1 = Mild Improvement (5 - 25%), or 0 = No Change (\<5%)
COMPLETED
NA
23 participants
12 weeks post-treatment
2023-03-07
Participant Flow
Participant milestones
| Measure |
All Subjects
All subjects will receive 1 truSculpt radiofrequency treatment in desired area.
TruSculpt: All subjects will receive 1 truSculpt radiofrequency treatment
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility Study of the TruSculpt Radiofrequency Device
Baseline characteristics by cohort
| Measure |
All Subjects
n=23 Participants
All subjects will receive 1 truSculpt radiofrequency treatment in desired area.
TruSculpt: All subjects will receive 1 truSculpt radiofrequency treatment
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
|
Visible fat bulges, skin laxity, or cellulite
|
23 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post-treatmentDegree of improvement in the treatment area at 12 weeks post-treatment compared with Baseline photo as assessed by the Investigator using Global Aesthetic Improvement Scale(GAIS): 4 = Very Significant Improvement (\>75%), 3 = Significant Improvement (51 - 75%), 2 = Moderate Improvement (26 - 50%), 1 = Mild Improvement (5 - 25%), or 0 = No Change (\<5%)
Outcome measures
| Measure |
All Subjects
n=18 Participants
All subjects will receive 1 truSculpt radiofrequency treatment in desired area.
TruSculpt: All subjects will receive 1 truSculpt radiofrequency treatment
|
|---|---|
|
Investigator Assessment of Improvement
|
0.67 score on a scale
Standard Deviation 0.47
|
Adverse Events
All Subjects
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Subjects
n=23 participants at risk
All subjects will receive 1 truSculpt radiofrequency treatment in desired area.
TruSculpt: All subjects will receive 1 truSculpt radiofrequency treatment
|
|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
91.3%
21/23 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Edema
|
47.8%
11/23 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Nodules
|
60.9%
14/23 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Post treatment pain/discomfort
|
26.1%
6/23 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Purpura
|
17.4%
4/23 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place