Thigh Circumference Reduction Study
May 6, 2011 updated by: Cutera Inc.
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Danville, California, United States, 94506
- Blackhawk Plastic Surgery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 66 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treated Thigh
The thigh treated with the RF device
|
Up to three treatments, one pass, dosage range of 15-60 kJ.
Other Names:
|
|
No Intervention: Untreated Thigh
The untreated thigh
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms
Time Frame: Baseline and 6 months post final treatment
|
Mean difference of change from baseline between two arms: [Treated arm - Untreated arm]
|
Baseline and 6 months post final treatment
|
|
Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms
Time Frame: Baseline and 6 months post final treatment
|
Mean difference of change from baseline between two arms: [Treated arm - Untreated arm]
|
Baseline and 6 months post final treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Subject Satisfaction
Time Frame: Baseline and 6 months post final treatment
|
Baseline and 6 months post final treatment
|
|
Adverse Events
Time Frame: At each visit (treatment and follow-up) or until resolution of AEs
|
At each visit (treatment and follow-up) or until resolution of AEs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephen J. Ronan, MD
- Principal Investigator: Christine Lee, MD
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
August 4, 2009
First Submitted That Met QC Criteria
August 5, 2009
First Posted (Estimate)
August 6, 2009
Study Record Updates
Last Update Posted (Estimate)
May 10, 2011
Last Update Submitted That Met QC Criteria
May 6, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CTCS002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.