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

This study has been terminated.
(The preliminary data from this pilot study did not indicate efficacy.)
Sponsor:
Information provided by (Responsible Party):
Cutera Inc.
ClinicalTrials.gov Identifier:
NCT00953160
First received: August 4, 2009
Last updated: June 21, 2013
Last verified: June 2013
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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: June 21, 2013
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 October 01, 2014