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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00953160
Recruitment Status : Terminated (The preliminary data from this pilot study did not indicate efficacy.)
First Posted : August 6, 2009
Results First Posted : March 17, 2011
Last Update Posted : July 2, 2013
Sponsor:
Information provided by (Responsible Party):
Cutera Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Cellulite Device: Cutera Radio Frequency Device Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010
Arms and Interventions
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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 Name: Callisto, TruForm, TruSculpt


Outcome Measures
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Primary Outcome Measures :
  1. Change in Circumference (cm) [ Time Frame: Baseline and 6 months post final treatment ]

Secondary Outcome Measures :
  1. Subject Satisfaction [ Time Frame: Baseline and 6 months post final treatment ]
  2. The Number of Participants With Adverse Events [ Time Frame: Up to 6 months after the last treatment ]
    At each visit (treatment and follow-up) or until resolution of AEs


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953160


Locations
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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
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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
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Responsible Party: Cutera Inc.
ClinicalTrials.gov Identifier: NCT00953160    
Other Study ID Numbers: C-09-TF-02
First Posted: August 6, 2009    Key Record Dates
Results First Posted: March 17, 2011
Last Update Posted: July 2, 2013
Last Verified: June 2013
Keywords provided by Cutera Inc.:
Cellulite
Adipose tissue
Circumference
Reduction
 Thigh
Abdomen
Flank
Additional relevant MeSH terms:
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Cellulite
Skin Manifestations