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

Cellulite Clinical Trial

Official title:

Pilot Study to Evaluate the Cutera RF Device for Reduction in Size of Localized Areas of the Body, Including, But Not Limited to, Areas on the Abdomen, Leg, and Arm

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00953160
• Other study ID #: C-09-TF-02
• Status: Terminated
• Phase: N/A
• Start date: April 2009
• Est. completion date: July 2010

Study information

• Verified date: August 2023
• Source: Cutera Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 76
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cellulite

Intervention

Device:
• Cutera Radio Frequency Device
Up to three treatments, one pass, dosage range of 15-60 kJ.

Locations

Country	Name	City	State
United States	Blackhawk Plastic Surgery	Danville	California
United States	Renu LaserSpa	Dublin	California
United States	New Jersey Plastic Surgery	Montclair	New Jersey
United States	Nashville Center for Laser and Facial Surgery	Nashville	Tennessee
United States	Calkin/Boudreaux Dermatology Associates	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Cutera Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Circumference (cm)		Baseline and 6 months post final treatment
Secondary	Subject Satisfaction		Baseline and 6 months post final treatment
Secondary	The Number of Participants With Adverse Events	At each visit (treatment and follow-up) or until resolution of AEs	Up to 6 months after the last treatment