Clinical trial NCT01665118: The Trusculpt (Radio Frequency) Device For Thigh Circumference Reduction
Official title: The Cutera Trusculpt Device For Thigh Circumference Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Fat
Keywords: Radio frequency
thigh
circumference
reduction
Lead sponsor: Cutera Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-15
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change of Thigh Circumference From Baseline
timeFrame: Comparison of Baseline to 12 weeks post- final treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Brisbane
country: United States
facility: Cutera Research Center
state: California
city: Montclair
country: United States
facility: New Jersey Plastic Surgery
state: New Jersey
city: Nashville
country: United States
facility: Nashville Center for Laser and Facial Surgery
state: Tennessee
Study officials:
name: Brian Biesman, MD
role: PRINCIPAL_INVESTIGATOR
name: Barry DiBernardo, MD
role: PRINCIPAL_INVESTIGATOR
name: Stephen Ronan, MD
role: PRINCIPAL_INVESTIGATOR
References: