Trial Outcomes & Findings for The Trusculpt (Radio Frequency) Device For Thigh Circumference Reduction (NCT NCT01665118)
NCT ID: NCT01665118
Last Updated: 2023-02-21
Results Overview
Change in thigh circumference from baseline of the treated thigh compared to the non-treated contra-lateral side at 12 weeks post-final treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
Comparison of Baseline to 12 weeks post- final treatment
Results posted on
2023-02-21
Participant Flow
Unit of analysis: Thighs
Participant milestones
| Measure |
All Study Participants
Subjects received RF treatments on one upper thigh (lateral and/or frontal and/or medial and/or posterior sides) according to randomization assignment and the opposite thigh served as the control.
|
|---|---|
|
Overall Study
STARTED
|
44 88
|
|
Overall Study
Thigh Treated With RF
|
44 44
|
|
Overall Study
Untreated Thigh
|
44 44
|
|
Overall Study
COMPLETED
|
26 52
|
|
Overall Study
NOT COMPLETED
|
18 36
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Trusculpt (Radio Frequency) Device For Thigh Circumference Reduction
Baseline characteristics by cohort
| Measure |
All Enrolled Subjects
n=44 Participants
Subjects received RF treatments on one upper thigh (lateral and/or frontal and/or medial and/or posterior sides) according to randomization assignment and the opposite thigh served as the control.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Comparison of Baseline to 12 weeks post- final treatmentChange in thigh circumference from baseline of the treated thigh compared to the non-treated contra-lateral side at 12 weeks post-final treatment.
Outcome measures
| Measure |
Treated Thigh
n=26 Participants
Treatment with Trusculpt (Radio Frequency) Device
|
Contra-lateral Untreated Thigh
n=26 Participants
No treatment with Trusculpt (Radio Frequency) Device
|
|---|---|---|
|
Change of Thigh Circumference From Baseline
|
.98 cm
Interval -0.3 to 2.05
|
.32 cm
Interval -0.55 to 1.8
|
Adverse Events
Treated Thigh
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Untreated Thigh
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treated Thigh
n=44 participants at risk
Trusculpt (Radio Frequency) Device
|
Untreated Thigh
n=44 participants at risk
No Treatment with RF device
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
93.2%
41/44 • 12 weeks post final treatment
|
0.00%
0/44 • 12 weeks post final treatment
|
|
Skin and subcutaneous tissue disorders
Edema
|
29.5%
13/44 • 12 weeks post final treatment
|
0.00%
0/44 • 12 weeks post final treatment
|
|
Skin and subcutaneous tissue disorders
Lumps
|
9.1%
4/44 • 12 weeks post final treatment
|
0.00%
0/44 • 12 weeks post final treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place