The Trusculpt (Radio Frequency) Device For Thigh Circumference Reduction

January 26, 2023 updated by: Cutera Inc.

The Cutera Trusculpt Device For Thigh Circumference Reduction

The objective of this study is to evaluate the safety and efficacy of the Trusculpt (Radio Frequency) device in the reduction of thigh circumference.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary efficacy variable for this study is the comparison of mean change in thigh circumference from baseline to 12 weeks between two arms. The primary research hypothesis is that the mean change in thigh circumference is ≥ 1 cm (indicating mean reduction).

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Brisbane, California, United States, 94005
        • Cutera Research Center
    • New Jersey
      • Montclair, New Jersey, United States, 07042
        • New Jersey Plastic Surgery
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Nashville Center for Laser and Facial Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • Minimum age of 18 years
  • Non-smoking for at least 3 months and willing to refrain from smoking for the duration of the study.
  • Post-menopausal, or on birth control and/or no plans to become pregnant for the duration of the study.
  • Body Mass Index (BMI) ≤ 30
  • Visible fat in the thigh / saddlebag area to be treated
  • Subject must be able to read, understand and sign the Consent Form
  • Subject must adhere to the follow-up schedule and study instructions
  • Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study (within 6 lbs of the weight measure at the baseline assessment)

Exclusion Criteria:

  • Taking weight-loss medications/supplements
  • Simultaneous participation in any other clinical study
  • Prior surgical treatment to the target area, e.g., liposuction or abdominoplasty
  • Prior treatment to the target area within the last 12 months e.g., radio frequency or cryolysis
  • Arteriosclerosis or weakened blood vessels
  • Heart disease
  • Thromboembolic disease
  • Diagnosed or documented immune system disorders (including Panniculitis)
  • Bleeding disorders
  • Presence of uncontrolled hypertension
  • Taking prescription anticoagulants
  • History of keloid formation
  • History of malignant tumors in the target area
  • Diabetes
  • Any disease or condition that could impair wound healing
  • Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles
  • Infection in the target area
  • Implanted electrical device(s) or metallic implants
  • Pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treated Thigh
Trusculpt (Radio Frequency) Device
Device: Trusculpt (Radio Frequency) Device
No Intervention: Untreated Contra-lateral Thigh
To be used as the self control in this split body study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Thigh Circumference From Baseline
Time Frame: Comparison of Baseline to 12 weeks post- final treatment
Change in thigh circumference from baseline of the treated thigh compared to the non-treated contra-lateral side at 12 weeks post-final treatment.
Comparison of Baseline to 12 weeks post- final treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cutera Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

August 10, 2012

First Submitted That Met QC Criteria

August 13, 2012

First Posted (Estimate)

August 15, 2012

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • C-12-TS05

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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