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Thigh Circumference Reduction Study

This study has been terminated.
(The study was terminated because the preliminary data did not indicate efficacy.)
Sponsor:
Information provided by:
Cutera Inc.
ClinicalTrials.gov Identifier:
NCT00953290
First received: August 4, 2009
Last updated: May 6, 2011
Last verified: May 2011

August 4, 2009
May 6, 2011
January 2009
January 2010   (final data collection date for primary outcome measure)
  • Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms [ Time Frame: Baseline and 6 months post final treatment ] [ Designated as safety issue: No ]
    Mean difference of change from baseline between two arms: [Treated arm - Untreated arm]
  • Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms [ Time Frame: Baseline and 6 months post final treatment ] [ Designated as safety issue: No ]
    Mean difference of change from baseline between two arms: [Treated arm - Untreated arm]
Reduction in thigh circumference [ Time Frame: 6 months post final treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00953290 on ClinicalTrials.gov Archive Site
  • Subject Satisfaction [ Time Frame: Baseline and 6 months post final treatment ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: At each visit (treatment and follow-up) or until resolution of AEs ] [ Designated as safety issue: Yes ]
  • Subject Satisfaction [ Time Frame: 6 months post final treatment ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: At each visit (treatment and follow-up) or until resolution of AEs ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Thigh Circumference Reduction Study
Cutera Radio Frequency Device for Thigh Circumference Reduction

The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction of thigh circumference.

The purpose of this study is to evaluate the Cutera radio frequency device for the new indication of reduction of thigh circumference.

At investigator's discretion, each subject will receive up to three treatments on one thigh and will be scheduled for two follow-up visits after the final treatment. The treated thigh will be clinically evaluated for side effects and both treated and untreated control thigh will be measured and photographed at each visit for analysis. Subjects will also be weighted at each visit and asked to fill out a survey during follow-up visits.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Reduction of Localized Excess Fat
Device: Cutera Radio Frequency Device
Up to three treatments, one pass, dosage range of 15-60 kJ.
Other Name: Callisto, TruForm, TruSculpt
  • Experimental: Treated Thigh
    The thigh treated with the RF device
    Intervention: Device: Cutera Radio Frequency Device
  • No Intervention: Untreated Thigh
    The untreated thigh
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Body Mass Index between 20 and 35
  • Presence of cellulite grades II, III or IV according to GLD scale
  • Visible bi-lateral thigh fat Thigh area to be treated to measure at least 30.0mm 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

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
  • Infection in the target area
  • Implanted electrical device(s)
  • Pregnant or lactating
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00953290
CTCS002
No
Stephanie Buech, Director of Clinical Research, Cutera Inc.
Cutera Inc.
Not Provided
Principal Investigator: Stephen J. Ronan, MD
Principal Investigator: Jacqueline Calkin, MD
Principal Investigator: Christine Lee, MD
Principal Investigator: Scott Kramer, MD
Cutera Inc.
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP