Feasibility Study of the TruSculpt Radiofrequency Device

NCT03018587 | Completed Results FDA Device

• 1 other identifier: C-16-TS12
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, prospective, open-label feasibility study of the truSculpt radiofrequency device.

Conditions

Tissue Tightening

Outcome Measures

Primary Outcomes (1)

• Investigator Assessment of Improvement

  Degree of improvement in the treatment area at 12 weeks post-treatment compared with Baseline photo as assessed by the Investigator using Global Aesthetic Improvement Scale(GAIS): 4 = Very Significant Improvement (\>75%), 3 = Significant Improvement (51 - 75%), 2 = Moderate Improvement (26 - 50%), 1 = Mild Improvement (5 - 25%), or 0 = No Change (\<5%)

  12 weeks post-treatment

Study Arms (1)

All subjects

EXPERIMENTAL

All subjects will receive 1 truSculpt radiofrequency treatment in desired area.

Device: TruSculpt

Interventions

TruSculpt DEVICE

All subjects will receive 1 truSculpt radiofrequency treatment

All subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female, 18 to 70 years of age (inclusive)
• Fitzpatrick Skin Type I - VI
• Has visible fat bulges,skin laxity, or cellulite in the treatment area
• 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 area during the study period.
• Subject must be able to read, understand and sign the Informed Consent Form.
• Subject must adhere to the follow-up schedule and study instructions.
• Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
• Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant.

You may not qualify if:

• Participation in a clinical trial of another device or drug in the target area during the study period.
• 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 that is local to the treatment area, such as surgical clips, plates and screws, intrauterine device (IUD), artificial heart valves or artificial joints.
• Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders.
• Diagnosed or documented immune system disorders.
• History of any disease or condition that could impair wound healing.
• History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen.
• Infection, dermatitis, rash or other skin abnormality in the target area.
• Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
• Pregnant or currently breastfeeding.
• As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (1)

Cutera Research Center

Brisbane, California, 94005, United States

Location

Results Point of Contact

• Title: Margot Doucette
• Organization: Cutera, Inc.

mdoucette@cutera.com

(415) 657-5518

Study Officials

• Stephen Ronan, M.D.

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 12, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 29, 2017
• Last Updated: March 7, 2023
• Results First Posted: March 7, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)