Trial Outcomes & Findings for Performance Evaluation of the truSculpt Radiofrequency Device for Lipolysis of Abdominal Fat (NCT NCT03433417)

Last Updated: 2023-03-17

Results Overview

Descriptive histological evaluation of abdominal tissue for selective fat necrosis, with sparing of the dermis and epidermis, following one truSculpt treatment vs. untreated bilateral control. A responder is a biopsy sample that shows necrosis or inflammatory immune cell response.

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

0 to 90 days

Results posted on

2023-03-17

Participant Flow

Unit of analysis: abdominal subareas

Participant milestones

Participant milestones
Measure	All Study Participants One truSculpt treatment will be performed before scheduled Abdominoplasty on one abdominal subarea. The other bilateral abdominal subarea will not be treated and act as a control. Two biopsies will be harvested from tissue removed during the Abdominoplasy: one from the treated area and one from the control area.
Overall Study STARTED	12 24
Overall Study Treatment With TruSculpt Device	12 12
Overall Study No Treatment With TruSculpt Device	12 12
Overall Study COMPLETED	12 24
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Performance Evaluation of the truSculpt Radiofrequency Device for Lipolysis of Abdominal Fat

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=12 Participants One truSculpt treatment Cutera truSculpt: one truSculpt treatment before scheduled Abdominoplasty on tissue to be removed during abdominoplasty
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0 to 90 days

Population: 24 biopsy samples were collected; however, the treatment side and untreated bilateral control side biopsy samples from 1 participant were lost during transit to the histology lab.

Outcome measures

Outcome measures
Measure	All Study Participants - Treatment Side n=11 Participants Biopsy sample of abdominal tissue taken immediately prior to participant's scheduled abdominoplasty from the side that received one truSculpt RF treatment 0 to 90 days prior to the scheduled abdominoplasty.	All Study Participants - Untreated Bilateral Control Side n=11 Participants Biopsy sample of abdominal tissue taken immediately prior to participant's scheduled abdominoplasty from the untreated bilateral control side.
Number of Participants Who's Abdominal Tissue Showed Necrosis or Inflammatory Immune Cell Response	10 Participants	0 Participants

Adverse Events

Treatment Side

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Control Side

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment Side n=12 participants at risk One truSculpt treatment Cutera truSculpt: One truSculpt treatment delivered 0 to 90 days before scheduled Abdominoplasty to one side of the tissue to be removed during abdominoplasty	Control Side n=12 participants at risk Untreated contralateral control
Skin and subcutaneous tissue disorders Erythema	100.0% 12/12 • Number of events 12 • 90 days	0.00% 0/12 • 90 days
Skin and subcutaneous tissue disorders Edema	100.0% 12/12 • Number of events 12 • 90 days	0.00% 0/12 • 90 days

Additional Information

Margot Doucette

Cutera, Inc.

Phone: (415) 657-5518

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place