Radio Frequency (RF) Device for Reduction in Size of Localized Areas of the Body

Pilot Study to Evaluate the Cutera RF Device for Reduction in Size of Localized Areas of the Body, Including, But Not Limited to, Areas on the Abdomen, Leg, and Arm

The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction in size of localized areas of the body.

Study Overview

• Status: Terminated
• Conditions: Cellulite
• Intervention / Treatment: Device: Cutera Radio Frequency Device

Detailed Description

The purpose of this study is to evaluate the Cutera radio frequency device for the new indication of reduction in size of localized areas of the body, including, but not limited to, areas on the abdomen, leg, and arm.

At investigator's discretion, each subject will receive up to three treatments and will be scheduled for two follow-up visits after the final treatment. The treated area will be measured and photographed ar each visit for analysis. Subjects will also be weighted at each visit and asked to fill out a survey during follow-up visits.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Danville, California, United States, 94506
      • Blackhawk Plastic Surgery
    • Dublin, California, United States, 94568
      • Renu LaserSpa
    • Sacramento, California, United States, 95825-6372
      • Calkin/Boudreaux Dermatology Associates
  • 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

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female or Male
• 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 with no plans to become pregnant for the duration of the study (female only)
• Minimum Body Mass Index of 20
• Visible fat in the area to be treated Area to be treated to measure at least 20.0mm in vertical fold, as measured with industry standard fat caliper
• 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 initial weight)

Exclusion Criteria:

• Significant weight fluctuation (+/-10 lbs) in the past 6 months
• Taking weight-loss medications/supplements
• Participation in any other clinical study
• Cellulite treatment within 3 months of the treatment
• Surgical or non-surgical treatments to the target area in the last 12 months, e.g., liposuction
• Prior treatment to the target area within the last 12 months
• Arteriosclerosis or weakened blood vessels
• Heart disease
• Thromboembolic disease
• Diagnosed or documented immune system disorders
• Bleeding disorders.
• Presence of uncontrolled hypertension
• Taking prescription anticoagulants
• History of keloid formation
• 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)
• Pregnant or lactating

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: RF treatment; Abdomen, flank or thigh treated with RF device	Device: Cutera Radio Frequency Device; Up to three treatments, one pass, dosage range of 15-60 kJ.; Other Names: Callisto, TruForm, TruSculpt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Circumference (cm)	Baseline and 6 months post final treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Satisfaction		Baseline and 6 months post final treatment
The Number of Participants With Adverse Events	At each visit (treatment and follow-up) or until resolution of AEs	Up to 6 months after the last treatment

Collaborators and Investigators

• Sponsor: Cutera Inc.
• Investigators: Principal Investigator: Adele Makow, MD; Principal Investigator: Brian Biesman, MD; Principal Investigator: Jacqueline Calkin, MD; Principal Investigator: Stephen Ronan, MD; Principal Investigator: Scott Kramer, MD; Principal Investigator: Barry DiBernardo, MD

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: August 4, 2009
• First Submitted That Met QC Criteria: August 5, 2009
• First Posted (Estimated): August 6, 2009

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Adipose tissue; Abdomen; Cellulite; Reduction; Circumference; Thigh; Flank
• Additional Relevant MeSH Terms: Skin Manifestations; Cellulite
• Other Study ID Numbers: C-09-TF-02