Radio Frequency (RF) Device for Reduction in Size of Localized Areas of the Body - Full Text View

Purpose

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.

Condition	Intervention
Cellulite	Device: Cutera Radio Frequency Device

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Further study details as provided by Cutera Inc.:

Primary Outcome Measures:

Change in Circumference (cm) [ Time Frame: Baseline and 6 months post final treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subject Satisfaction [ Time Frame: Baseline and 6 months post final treatment ] [ Designated as safety issue: No ]
The Number of Participants With Adverse Events [ Time Frame: Up to 6 months after the last treatment ] [ Designated as safety issue: Yes ]
At each visit (treatment and follow-up) or until resolution of AEs

Enrollment:	76
Study Start Date:	April 2009
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: Callisto, TruForm, TruSculpt

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00953160

Locations

United States, California
Blackhawk Plastic Surgery
Danville, California, United States, 94506
Renu LaserSpa
Dublin, California, United States, 94568
Calkin/Boudreaux Dermatology Associates
Sacramento, California, United States, 95825-6372
United States, New Jersey
New Jersey Plastic Surgery
Montclair, New Jersey, United States, 07042
United States, Tennessee
Nashville Center for Laser and Facial Surgery
Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

Cutera Inc.

Investigators

Principal Investigator:	Brian Biesman, MD
Principal Investigator:	Jacqueline Calkin, MD
Principal Investigator:	Stephen Ronan, MD
Principal Investigator:	Scott Kramer, MD
Principal Investigator:	Adele Makow, MD
Principal Investigator:	Barry DiBernardo, MD

More Information

No publications provided

Responsible Party:	Stephanie Buech, Director of Clinical Research, Cutera Inc.
ClinicalTrials.gov Identifier:	NCT00953160 History of Changes
Other Study ID Numbers:	C-09-TF-02
Study First Received:	August 4, 2009
Results First Received:	February 25, 2011
Last Updated:	March 16, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Cutera Inc.:

Cellulite
Adipose tissue
Circumference
Reduction

Thigh
Abdomen
Flank

ClinicalTrials.gov processed this record on May 23, 2013