Radio Frequency (RF) Device for Reduction in Size of Localized Areas of the Body

NCT ID: NCT00953160

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-07-31

Brief Summary

The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction in size of localized areas of the body.

Detailed Description

The purpose of this study is to evaluate the Cutera radio frequency device for the new indication of reduction in size of localized areas of the body, including, but not limited to, areas on the abdomen, leg, and arm.

At investigator's discretion, each subject will receive up to three treatments and will be scheduled for two follow-up visits after the final treatment. The treated area will be measured and photographed ar each visit for analysis. Subjects will also be weighted at each visit and asked to fill out a survey during follow-up visits.

Conditions

Cellulite

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RF treatment

Abdomen, flank or thigh treated with RF device

Group Type: EXPERIMENTAL

Cutera Radio Frequency Device

Intervention Type: DEVICE

Up to three treatments, one pass, dosage range of 15-60 kJ.

Interventions

Cutera Radio Frequency Device

Up to three treatments, one pass, dosage range of 15-60 kJ.

Intervention Type: DEVICE

Other Intervention Names

Callisto, TruForm, TruSculpt

Eligibility Criteria

Inclusion Criteria

• Female or Male
• 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 with no plans to become pregnant for the duration of the study (female only)
• Minimum Body Mass Index of 20
• Visible fat in the area to be treated Area to be treated to measure at least 20.0mm in vertical fold, as measured with industry standard fat caliper
• 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 initial weight)

Exclusion Criteria

• Significant weight fluctuation (+/-10 lbs) in the past 6 months
• Taking weight-loss medications/supplements
• Participation in any other clinical study
• Cellulite treatment within 3 months of the treatment
• Surgical or non-surgical treatments to the target area in the last 12 months, e.g., liposuction
• Prior treatment to the target area within the last 12 months
• Arteriosclerosis or weakened blood vessels
• Heart disease
• Thromboembolic disease
• Diagnosed or documented immune system disorders
• Bleeding disorders.
• Presence of uncontrolled hypertension
• Taking prescription anticoagulants
• History of keloid formation
• 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)
• Pregnant or lactating

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cutera Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Biesman, MD

Role: PRINCIPAL_INVESTIGATOR

Jacqueline Calkin, MD

Role: PRINCIPAL_INVESTIGATOR

Stephen Ronan, MD

Role: PRINCIPAL_INVESTIGATOR

Scott Kramer, MD

Role: PRINCIPAL_INVESTIGATOR

Adele Makow, MD

Role: PRINCIPAL_INVESTIGATOR

Barry DiBernardo, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Blackhawk Plastic Surgery

Danville, California, United States

Renu LaserSpa

Dublin, California, United States

Calkin/Boudreaux Dermatology Associates

Sacramento, 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-09-TF-02

Identifier Type: -

Identifier Source: org_study_id