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Trial Outcomes & Findings for Multi-Center Pilot Study of Cutera truSculpt Device (NCT NCT03782545)

NCT ID: NCT03782545

Last Updated: 2023-09-13

Results Overview

Global Aesthetic Improvement Scale will be assessed at 12 weeks post final treatment by the investigator by comparing against Baseline photos Higher scores indicate better outcomes 0= No change 1. Mild Improvement 2. Moderate improvement 3. Significant Improvement

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

12 weeks post final treatment

Results posted on

2023-09-13

Participant Flow

Participant milestones

Participant milestones
Measure
Treatment With the truSculpt RF Device
Subjects will be treated with the truSculpt RF device
Overall Study
STARTED
34
Overall Study
COMPLETED
30
Overall Study
NOT COMPLETED
4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multi-Center Pilot Study of Cutera truSculpt Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treatment With the truSculpt RF Device
n=34 Participants
Subjects will be treated with the truSculpt RF device
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
34 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
30 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
30 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks post final treatment

Global Aesthetic Improvement Scale will be assessed at 12 weeks post final treatment by the investigator by comparing against Baseline photos Higher scores indicate better outcomes 0= No change 1. Mild Improvement 2. Moderate improvement 3. Significant Improvement

Outcome measures

Outcome measures
Measure
Treatment With the truSculpt RF Device
n=30 Participants
Subjects will be treated with the truSculpt RF device
GAIS at 12 Weeks Post Final Treatment
2 score on a scale
Standard Deviation 0.94

Adverse Events

Treatment With the truSculpt RF Device

Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Treatment With the truSculpt RF Device
n=34 participants at risk
Subjects will be treated with the truSculpt RF device
Skin and subcutaneous tissue disorders
Erythema
64.7%
22/34 • up to 12 weeks post final treatment
Skin and subcutaneous tissue disorders
Edema
5.9%
2/34 • up to 12 weeks post final treatment

Additional Information

Margot Doucette

Cutera

Phone: 415-656-9612

Results disclosure agreements

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