Radio Frequency (RF) Device for Reduction in Size of Localized Areas of the Body
Stopped early · Not applicable
Conditions studied: Cellulite
In brief
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.
Key facts
- Study ID
- NCT00953160
- Run by
- Cutera Inc.
- People needed
- 76
- Starts
- 2009-04-01
- Expected to finish
- 2010-07-01
- Last updated by the study team
- 2023-09-18
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Blackhawk Plastic Surgery — Danville, California, United States
- Renu LaserSpa — Dublin, California, United States
- Calkin/Boudreaux Dermatology Associates — Sacramento, California, United States
- New Jersey Plastic Surgery — Montclair, New Jersey, United States
- Nashville Center for Laser and Facial Surgery — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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