The Trusculpt (Radio Frequency) Device For Thigh Circumference Reduction

NCT01665118 | Completed Results FDA Device

• 1 other identifier: C-12-TS05
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

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.

Conditions

Body Fat

Keywords

Radio frequency; thigh; circumference; reduction

Outcome Measures

Primary Outcomes (1)

• Change of Thigh Circumference From Baseline

  Change in thigh circumference from baseline of the treated thigh compared to the non-treated contra-lateral side at 12 weeks post-final treatment.

  Comparison of Baseline to 12 weeks post- final treatment

Study Arms (2)

Treated Thigh

EXPERIMENTAL

Trusculpt (Radio Frequency) Device

Device: Trusculpt (Radio Frequency) Device

Untreated Contra-lateral Thigh

NO INTERVENTION

To be used as the self control in this split body study.

Interventions

Trusculpt (Radio Frequency) Device DEVICE

Treated Thigh

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (3)

Cutera Research Center

Brisbane, California, 94005, United States

Location

New Jersey Plastic Surgery

Montclair, New Jersey, 07042, United States

Location

Nashville Center for Laser and Facial Surgery

Nashville, Tennessee, 37203, United States

Location

Results Point of Contact

• Title: Margot Doucette
• Organization: Cutera

mdoucette@cutera.com

415-657-5518

Study Officials

• Brian Biesman, MD

  PRINCIPAL INVESTIGATOR

• Barry DiBernardo, MD

  PRINCIPAL INVESTIGATOR

• Stephen Ronan, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2012
• First Posted: August 15, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 21, 2023
• Results First Posted: February 21, 2023

Record last verified: 2023-01

Locations

US (3)