Reduction of Localized Excess Fat Clinical Trial
Official title:
Cutera Radio Frequency Device for Thigh Circumference Reduction
| Verified date | May 2011 |
| Source | Cutera Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction of thigh circumference.
| Status | Terminated |
| Enrollment | 4 |
| Est. completion date | January 2010 |
| Est. primary completion date | January 2010 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Blackhawk Plastic Surgery | Danville | California |
| Lead Sponsor | Collaborator |
|---|---|
| Cutera Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms | Mean difference of change from baseline between two arms: [Treated arm - Untreated arm] | Baseline and 6 months post final treatment | No |
| Primary | Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms | Mean difference of change from baseline between two arms: [Treated arm - Untreated arm] | Baseline and 6 months post final treatment | No |
| Secondary | Subject Satisfaction | Baseline and 6 months post final treatment | No | |
| Secondary | Adverse Events | At each visit (treatment and follow-up) or until resolution of AEs | Yes |