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Trial Outcomes & Findings for Multi-Center Pilot Study of truSculpt Device (NCT NCT03433430)

NCT ID: NCT03433430

Last Updated: 2023-09-18

Results Overview

Degree of Improvement in body fat as assessed by Investigator using the Global Aesthetic Improvement Scale (GAIS:) +4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, and 0=No Change Higher scores indicate better outcomes

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

12 weeks post final treatment

Results posted on

2023-09-18

Participant Flow

Participant milestones

Participant milestones
Measure
truSculpt
Treatment with the truSculpt RF device
Overall Study
STARTED
9
Overall Study
COMPLETED
8
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multi-Center Pilot Study of truSculpt Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
truSculpt
n=9 Participants
Treatment with the truSculpt RF device
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
9 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
7 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
8 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: 12 weeks post final treatment

Degree of Improvement in body fat as assessed by Investigator using the Global Aesthetic Improvement Scale (GAIS:) +4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, and 0=No Change Higher scores indicate better outcomes

Outcome measures

Outcome measures
Measure
truSculpt
n=8 Participants
Treatment with the truSculpt RF device
Body Fat Assessment by Investigator
1.88 score on a scale
Standard Deviation 1.13

Adverse Events

truSculpt

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
truSculpt
n=9 participants at risk
Treatment with the truSculpt RF device
Skin and subcutaneous tissue disorders
Erythema
100.0%
9/9 • 12 weeks post-final treatment, up to 6 months
Skin and subcutaneous tissue disorders
Pain
22.2%
2/9 • 12 weeks post-final treatment, up to 6 months
Skin and subcutaneous tissue disorders
Tenderness
11.1%
1/9 • 12 weeks post-final treatment, up to 6 months

Additional Information

Margot Doucette

Cutera

Phone: 415-656-9612

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place