Multi-Center Pilot Study of Cutera truSculpt Device

NCT03782545 | Completed Results FDA Device

• 1 other identifier: C-18-TS-18
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Treatment for Cellulite on the Stomach and Flanks

Outcome Measures

Primary Outcomes (1)

• GAIS at 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

  12 weeks post final treatment

Study Arms (1)

Treatment with the truSculpt RF device

EXPERIMENTAL

Subjects will be treated with the truSculpt RF device

Device: Cutera truSculpt Device

Interventions

Cutera truSculpt Device DEVICE

The Cutera truSculpt Device uses radio frequency (RF) energy to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as temporary reduction in the appearance of cellulite.

Treatment with the truSculpt RF device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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.
• History of any disease or condition that could impair wound healing.
• History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing.
• 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.

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (3)

Laser and Skin Surgery Center of Northern California

Sacramento, California, 95816, United States

Location

Advanced Dermatology

Glencoe, Illinois, 60022, United States

Location

Union Square Dermatology

New York, New York, 10003, United States

Location

Results Point of Contact

• Title: Margot Doucette
• Organization: Cutera

mdoucette@cutera.com

415-656-9612

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open label study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A type of intervention model describing a clinical trial in which all participants receive the same intervention/treatment.

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 20, 2018
• Study Start: May 11, 2018
• Primary Completion: December 19, 2018
• Study Completion: December 19, 2018
• Last Updated: September 13, 2023
• Results First Posted: September 13, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

US (3)