Radio Frequency Device for Reduction in Size of Localized Areas of the Body - Tabular View

Tracking Information
First Received Date ^ICMJE	August 4, 2009
Last Updated Date	January 25, 2010
Start Date ^ICMJE	April 2009
Estimated Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 5, 2009)	Reduction in size of the treated area [ Time Frame: 6 months post final treatment ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00953160 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 5, 2009)	Subject satisfaction [ Time Frame: 6 months post final treatment ] [ Designated as safety issue: No ] Adverse events [ Time Frame: At each visit (treatment and follow-up) or until resolution of AEs ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Radio Frequency Device for Reduction in Size of Localized Areas of the Body
Official Title ^ICMJE	Pilot Study to Evaluate the Cutera Radio Frequency Device for Reduction in Size of Localized Areas of the Body, Including, But Not Limited to, Areas on the Abdomen, Leg, and Arm
Brief Summary	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.
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.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Cellulite
Intervention ^ICMJE	Device: Cutera Radio Frequency Device Up to three treatments, one pass, dosage range of 15-60 kJ.
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	80
Estimated Completion Date	December 2010
Estimated Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00953160
Responsible Party	VP of Clinical Development, Cutera Inc.
Study ID Numbers ^ICMJE	C-09-TF-02
Study Sponsor ^ICMJE	Cutera Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Cutera Inc.
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP