Clinical trial NCT00953160: Radio Frequency (RF) Device for Reduction in Size of Localized Areas of the Body
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cellulite
Keywords: Cellulite
Adipose tissue
Circumference
Reduction
Thigh
Abdomen
Flank
Lead sponsor: Cutera Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-06
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Circumference (cm)
timeFrame: Baseline and 6 months post final treatment
Secondary outcomes:
measure: Subject Satisfaction
timeFrame: Baseline and 6 months post final treatment
measure: The Number of Participants With Adverse Events
timeFrame: Up to 6 months after the last treatment
Other outcomes:
Locations:
city: Danville
country: United States
facility: Blackhawk Plastic Surgery
state: California
city: Dublin
country: United States
facility: Renu LaserSpa
state: California
city: Sacramento
country: United States
facility: Calkin/Boudreaux Dermatology Associates
state: California
city: Montclair
country: United States
facility: New Jersey Plastic Surgery
state: New Jersey
city: Nashville
country: United States
facility: Nashville Center for Laser and Facial Surgery
state: Tennessee
Study officials:
name: Brian Biesman, MD
role: PRINCIPAL_INVESTIGATOR
name: Jacqueline Calkin, MD
role: PRINCIPAL_INVESTIGATOR
name: Stephen Ronan, MD
role: PRINCIPAL_INVESTIGATOR
name: Scott Kramer, MD
role: PRINCIPAL_INVESTIGATOR
name: Adele Makow, MD
role: PRINCIPAL_INVESTIGATOR
name: Barry DiBernardo, MD
role: PRINCIPAL_INVESTIGATOR
References: