The Trusculpt (Radio Frequency) Device For Thigh Circumference Reduction

Not Applicable

Completed

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

Detailed Description: The primary efficacy variable for this study is the comparison of mean change in thigh circumference from baseline to 12 weeks between two arms. The primary research hypothesis is that the mean change in thigh circumference is ≥ 1 cm (indicating mean reduction).

Recruitment & Eligibility

Inclusion Criteria

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)

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Treated Thigh	Trusculpt (Radio Frequency) Device	Trusculpt (Radio Frequency) Device

Primary Outcome Measures

Name	Time	Method
Change of Thigh Circumference From Baseline	Comparison of Baseline to 12 weeks post- final treatment	Change in thigh circumference from baseline of the treated thigh compared to the non-treated contra-lateral side at 12 weeks post-final treatment.

Secondary Outcome Measures

Name	Time	Method

Locations (3): Nashville Center for Laser and Facial Surgery
🇺🇸
Nashville, Tennessee, United States
Cutera Research Center
🇺🇸
Brisbane, California, United States
New Jersey Plastic Surgery
🇺🇸
Montclair, New Jersey, United States