Status:
TERMINATED
Radio Frequency (RF) Device for Reduction in Size of Localized Areas of the Body
Lead Sponsor:
Cutera Inc.
Conditions:
Cellulite
Eligibility:
All Genders
18-55 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 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 abdom...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00953160
Start Date
April 1 2009
End Date
July 1 2010
Last Update
September 18 2023
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Blackhawk Plastic Surgery
Danville, California, United States, 94506
2
Renu LaserSpa
Dublin, California, United States, 94568
3
Calkin/Boudreaux Dermatology Associates
Sacramento, California, United States, 95825-6372
4
New Jersey Plastic Surgery
Montclair, New Jersey, United States, 07042