Feasibility Study of the TruSculpt Radiofrequency Device

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

Study Overview

• Status: Completed
• Conditions: Tissue Tightening
• Intervention / Treatment: Device: TruSculpt

Detailed Description

A single-center, prospective, open-label study to evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for optimal delivery of thermal energy to the skin.

• Study Type: Interventional
• Enrollment (Actual): 23
• 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: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or Female, 18 to 70 years of age (inclusive)
2. Fitzpatrick Skin Type I - VI
3. Has visible fat bulges,skin laxity, or cellulite in the treatment area
4. Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study.
5. Subject must agree to not undergo any other procedure(s) in the treatment area during the study period.
6. Subject must be able to read, understand and sign the Informed Consent Form.
7. Subject must adhere to the follow-up schedule and study instructions.
8. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
9. 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. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
3. 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.
4. Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders.
5. Diagnosed or documented immune system disorders.
6. History of any disease or condition that could impair wound healing.
7. History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen.
8. Infection, dermatitis, rash or other skin abnormality in the target area.
9. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
10. Pregnant or currently breastfeeding.
11. 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: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All subjects; All subjects will receive 1 truSculpt radiofrequency treatment in desired area.	Device: TruSculpt; All subjects will receive 1 truSculpt radiofrequency treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject assessment of improvement at 12 weeks post-treatment	Subject will complete a questionnaire to asses improvement of treated area.	At 12 weeks post-treatment
Subject satisfaction level at 12 weeks post-treatment	Subject will complete a questionnaire to asses treatment satisfaction.	At 12 weeks post-treatment
Subject pain levels during treatment	Using a numeric scale of 0 to 10, subject's will be asked to rate the average level of pain experienced during treatment.	Within 5 to 10 minutes post-treatment

Collaborators and Investigators

• Sponsor: Cutera Inc.
• Investigators: Principal Investigator: Stephen Ronan, M.D., Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 29, 2017

Study Registration Dates

• First Submitted: January 9, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimate): January 12, 2017

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: C-16-TS12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: None. No individual participant data will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes