Status:
TERMINATED
Thigh Circumference Reduction Study
Lead Sponsor:
Cutera Inc.
Conditions:
Reduction of Localized Excess Fat
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction of thigh circumference.
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00953290
Start Date
January 1 2009
End Date
January 1 2010
Last Update
May 10 2011
Active Locations (1)
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1
Blackhawk Plastic Surgery
Danville, California, United States, 94506