Radio Frequency (RF) Device for Reduction in Size of Localized Areas of the Body

Not Applicable

Terminated

Brief Summary: 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.

Detailed Description: The purpose of this study is to evaluate the Cutera radio frequency device for the new indication of reduction in size of localized areas of the body, including, but not limited to, areas on the abdomen, leg, and arm.

At investigator's discretion, each subject will receive up to three treatments and will be scheduled for two follow-up visits after the final treatment. The treated area will be measured and photographed ar each visit for analysis. Subjects will also be weighted at each visit and asked to fill out a survey during follow-up visits.

Recruitment & Eligibility

Inclusion Criteria

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)

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, large moles
Infection in the target area
Implanted electrical device(s)
Pregnant or lactating

Primary Outcome Measures

Name	Time	Method
Change in Circumference (cm)	Baseline and 6 months post final treatment

Secondary Outcome Measures

Name	Time	Method
Subject Satisfaction	Baseline and 6 months post final treatment
The Number of Participants With Adverse Events	Up to 6 months after the last treatment	At each visit (treatment and follow-up) or until resolution of AEs

Locations (5): 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
Blackhawk Plastic Surgery
🇺🇸Danville, California, United States