Multi-Center Pilot Study of Cutera truSculpt Device

Study Overview
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Brief Summary
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Exploratory study to evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.

Detailed Description
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This study will evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.

Official Title
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Multi-Center Pilot Study of Cutera truSculpt Device

Conditions
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Treatment for Cellulite on the Stomach and Flanks

Intervention / Treatment
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* Device: Cutera truSculpt Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Subject must be able to read, understand and sign the Informed Consent Form. 2. Female or Male, 18 to 65 years of age (inclusive). 3. Subject has visible fat bulges in the area to be treated. 4. Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study. 5. Subject must agree to not undergo any other procedure(s) in the treatment region during the study period. 6. Subject must adhere to the follow-up schedule and study instructions. 7. Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study. 8. Willing to have photographs taken of the treatment area and agree to use of photographs for presentation, (educational and/or marketing), publications, and any additional marketing purposes. 9. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control prior to enrollment and during the entire course of the study. Exclusion Criteria: Participation in a clinical trial of another device or drug within 1 month of study participation, or during the study period. Any type of prior cosmetic treatment to the target area within 6 months of study participation. Any prior invasive cosmetic surgery to the target area, such as liposuction. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant. Has metal implant(s) within the body, such as artificial heart valves. Significant uncontrolled concurrent illness that in the opinion of the Investigator would make the subject unsuitable for inclusion. History of any disease or condition that could impair wound healing. History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing. Skin abnormality in the treatment area that in the opinion of the Investigator would make the subject unsuitable for inclusion. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation. Allergy or sensitivity to Tegaderm. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study or a condition that would compromise the subject's ability to comply with the study requirements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A type of intervention model describing a clinical trial in which all participants receive the same intervention/treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with the truSculpt RF device<br>Subjects will be treated with the truSculpt RF device | Device: Cutera truSculpt Device<br>* The Cutera truSculpt Device uses radio frequency (RF) energy to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as temporary reduction in the appearance of cellulite.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GAIS at 12 Weeks Post Final Treatment | Global Aesthetic Improvement Scale will be assessed at 12 weeks post final treatment by the investigator by comparing against Baseline photos Higher scores indicate better outcomes 0= No change Mild Improvement Moderate improvement Significant Improvement | 12 weeks post final treatment |