CompletedNot Applicable

Multi-Center Pilot Study of Cutera truSculpt Device

United States34 participantsStarted 2018-05-11

Plain-language summary

Exploratory study to evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Participation in a clinical trial of another device or drug within 1 month of study participation, or during the study period.
✕. Any type of prior cosmetic treatment to the target area within 6 months of study participation.
✕. Any prior invasive cosmetic surgery to the target area, such as liposuction.
✕. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
✕. Has metal implant(s) within the body, such as artificial heart valves.
✕. Significant uncontrolled concurrent illness that in the opinion of the Investigator would make the subject unsuitable for inclusion.
✕. History of any disease or condition that could impair wound healing.
✕. History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing.

GAIS at 12 Weeks Post Final Treatment

Timeframe: 12 weeks post final treatment

NCT IDNCT03782545

SponsorCutera Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-12-19

Results submitted2023-08-03