Performance Evaluation of the truSculpt Radiofrequency Device for Lipolysis of Abdominal Fat

NCT03433417 | Completed Results FDA Device

• 1 other identifier: C-17-TS13
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical Study to Evaluate the Performance the truSculpt Radiofrequency Device for Lipolysis of Abdominal Fat

Conditions

Body Fat

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who's Abdominal Tissue Showed Necrosis or Inflammatory Immune Cell Response

  Descriptive histological evaluation of abdominal tissue for selective fat necrosis, with sparing of the dermis and epidermis, following one truSculpt treatment vs. untreated bilateral control. A responder is a biopsy sample that shows necrosis or inflammatory immune cell response.

  0 to 90 days

Study Arms (2)

Treatment Side

EXPERIMENTAL

One truSculpt treatment

Device: Cutera truSculpt

Control Side

NO INTERVENTION

Untreated contralateral control

Interventions

Cutera truSculpt DEVICE

One truSculpt treatment delivered 0 to 90 days before scheduled Abdominoplasty to one side of the tissue to be removed during abdominoplasty

Treatment Side

Eligibility Criteria

• Age: 24 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or Female, 24 to 60 years of age (inclusive)
• Fitzpatrick Skin Type I - VI (Appendix 3)
• Has visible fat bulges or skin laxity in the abdominal region
• Scheduled to undergo surgery (abdominoplasty).
• 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 abdominal region 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.
• Subject must adhere to the same diet/ exercise/medication regimen for the entire course of the study.
• Willing to provide histology samples during the surgery from the intended to be harvested areas.
• 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.
• Any type of prior cosmetic treatment to the target area within 12 months of study participation e.g., radiofrequency, cryolysis or light-based treatments.
• 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 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.
• History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing in the treatment area.
• 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, MD

  Cutera Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 14, 2018
• Study Start: June 15, 2017
• Primary Completion: March 15, 2018
• Study Completion: March 15, 2018
• Last Updated: March 17, 2023
• Results First Posted: March 17, 2023

Record last verified: 2023-02

Locations

US (1)