N/A
Completed N=34
Multi-Center Pilot Study of Cutera truSculpt Device
Treatment for Cellulite on the Stomach and Flanks
Source: ClinicalTrials.gov NCT03782545 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcomePrimary: GAIS at 12 Weeks Post Final Treatment — 2 score on a scale
Summary
Exploratory study to evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY GAIS at 12 Weeks Post Final Treatment |
2 | — |
Eligibility Criteria
Inclusion Criteria
- 1. Subject must be able to read, understand and sign the Informed Consent Form.
- Female or Male, 18 to 65 years of age (inclusive). 3. Subject has visible fat bulges in the area to be treated. 4. Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study.
- Subject must agree to not undergo any other procedure(s) in the treatment region during the study period.
- Subject must adhere to the follow-up schedule and study instructions. 7. Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study.
- Willing to have photographs taken of the treatment area and agree to use of photographs for presentation, (educational and/or marketing), publications, and any additional marketing purposes.
- For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control prior to enrollment and during the entire course of the study.
Exclusion Criteria
- 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.
- Skin abnormality in the treatment area that in the opinion of the Investigator would make the subject unsuitable for inclusion.
- Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
- Allergy or sensitivity to Tegaderm.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study or a condition that would compromise the subject's ability to comply with the study requirements.
Data sourced from ClinicalTrials.gov (NCT03782545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.