Thigh Circumference Reduction Study

NCT ID: NCT00953290

Last Updated: 2011-05-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-01-31

Brief Summary

The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction of thigh circumference.

Detailed Description

The purpose of this study is to evaluate the Cutera radio frequency device for the new indication of reduction of thigh circumference.

At investigator's discretion, each subject will receive up to three treatments on one thigh and will be scheduled for two follow-up visits after the final treatment. The treated thigh will be clinically evaluated for side effects and both treated and untreated control thigh will be measured and photographed at each visit for analysis. Subjects will also be weighted at each visit and asked to fill out a survey during follow-up visits.

Conditions

Reduction of Localized Excess Fat

Study Design

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

Study Groups

Treated Thigh

The thigh treated with the RF device

Group Type: EXPERIMENTAL

Cutera Radio Frequency Device

Intervention Type: DEVICE

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

Untreated Thigh

The untreated thigh

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

• Body Mass Index between 20 and 35
• Presence of cellulite grades II, III or IV according to GLD scale
• Visible bi-lateral thigh fat Thigh area to be treated to measure at least 30.0mm 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

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
• Infection in the target area
• Implanted electrical device(s)
• Pregnant or lactating

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cutera Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Cutera Inc.

Principal Investigators

Stephen J. Ronan, MD

Role: PRINCIPAL_INVESTIGATOR

Jacqueline Calkin, MD

Role: PRINCIPAL_INVESTIGATOR

Christine Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Scott Kramer, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Blackhawk Plastic Surgery

Danville, California, United States

Countries

United States

Other Identifiers

CTCS002

Identifier Type: -

Identifier Source: org_study_id