The Trusculpt (Radio Frequency) Device For Thigh Circumference Reduction

NCT ID: NCT01665118

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-06-30

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).

Conditions

Body Fat

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treated Thigh

Trusculpt (Radio Frequency) Device

Group Type: EXPERIMENTAL

Trusculpt (Radio Frequency) Device

Intervention Type: DEVICE

Untreated Contra-lateral Thigh

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Trusculpt (Radio Frequency) Device

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cutera Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Biesman, MD

Role: PRINCIPAL_INVESTIGATOR

Barry DiBernardo, MD

Role: PRINCIPAL_INVESTIGATOR

Stephen Ronan, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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

Countries

United States

Other Identifiers

C-12-TS05

Identifier Type: -

Identifier Source: org_study_id