The Trusculpt (Radio Frequency) Device For Thigh Circumference Reduction

Completed · Not applicable

Conditions studied: Body Fat

In brief

The objective of this study is to evaluate the safety and efficacy of the Trusculpt (Radio Frequency) device in the reduction of thigh circumference.

Key facts

Study ID

NCT01665118

Run by

Cutera Inc.

People needed

44

Starts

2012-08-01

Expected to finish

2013-06-01

Last updated by the study team

2023-02-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Female
• 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 and/or no plans to become pregnant for the duration of the study.
• Body Mass Index (BMI) ≤ 30
• Visible fat in the thigh / saddlebag area to be treated
• 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 the weight measure at the baseline assessment)

You may not qualify if…

• Taking weight-loss medications/supplements
• Simultaneous participation in any other clinical study
• Prior surgical treatment to the target area, e.g., liposuction or abdominoplasty
• Prior treatment to the target area within the last 12 months e.g., radio frequency or cryolysis
• Arteriosclerosis or weakened blood vessels
• Heart disease
• Thromboembolic disease
• Diagnosed or documented immune system disorders (including Panniculitis)
• Bleeding disorders
• Presence of uncontrolled hypertension
• Taking prescription anticoagulants
• History of keloid formation
• History of 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) or metallic implants
• Pregnant or lactating

Where it is running

• Cutera Research Center — Brisbane, 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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