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

A Single-center, Prospective, Non-randomized, Open-label Clinical Study to Evaluate the Performance of the truSculpt Radiofrequency Device for Non-invasive Fat Reduction in Abdominal Tissue in Subjects Who Are Scheduled for Abdominoplasty

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

Study Overview

• Status: Completed
• Conditions: Body Fat
• Intervention / Treatment: Device: Cutera truSculpt

Detailed Description

A single-center, prospective, non-randomized, open-label study to evaluate the truSculpt Radiofrequency Device for non-invasive fat reduction in abdominal tissue for up to 14 subjects. Measurement will be histological evaluation of tissue for selective fat necrosis, with sparing of the dermis and epidermis, following truSculpt treatment vs. untreated contralateral control.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Brisbane, California, United States, 94005
      • Cutera Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or Female, 24 to 60 years of age (inclusive)
2. Fitzpatrick Skin Type I - VI (Appendix 3)
3. Has visible fat bulges or skin laxity in the abdominal region
4. Scheduled to undergo surgery (abdominoplasty).
5. Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study.
6. Subject must agree to not undergo any other procedure(s) in the abdominal region during the study period.
7. Subject must be able to read, understand and sign the Informed Consent Form.
8. Subject must adhere to the follow-up schedule and study instructions.
9. Subject must adhere to the same diet/ exercise/medication regimen for the entire course of the study.
10. Willing to provide histology samples during the surgery from the intended to be harvested areas.
11. 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.

Exclusion Criteria:

1. Participation in a clinical trial of another device or drug in the target area during the study period.
2. Any type of prior cosmetic treatment to the target area within 12 months of study participation e.g., radiofrequency, cryolysis or light-based treatments.
3. Any prior invasive cosmetic surgery to the target area, such as liposuction.
4. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
5. Has metal implant(s) within the body, such as surgical clips, plates and screws, intrauterine device (IUD), artificial heart valves or artificial joints.
6. Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders.
7. Diagnosed or documented immune system disorders.
8. History of any disease or condition that could impair wound healing.
9. History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen.
10. History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing in the treatment area.
11. Infection, dermatitis, rash or other skin abnormality in the target area.
12. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
13. Pregnant or currently breastfeeding.
14. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Side; One truSculpt treatment	Device: Cutera truSculpt; One truSculpt treatment delivered 0 to 90 days before scheduled Abdominoplasty to one side of the tissue to be removed during abdominoplasty
No Intervention: Control Side; Untreated contralateral control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events	Identification and Severity of treatment emergent Adverse Events (AE), where 1=Mild (requires minimal or no treatment and does not interfere with the Subject's daily activities), 2=Moderate (may cause some interference with functioning) and 3=Severe (interrupts Subject's usual daily activity and may require treatment).	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Cutera Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2017
• Primary Completion (Actual): March 15, 2018
• Study Completion (Actual): March 15, 2018

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: C-17-TS13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No