Multi-Center Pilot Study of truSculpt Device

Study Overview
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Brief Summary
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An exploratory pilot study to evaluate the safety, efficacy and ergonomics of Cutera truSculpt device

Detailed Description
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This is a multi-center, pilot study in approximately 40 subjects, ages 18 to 65. Subjects will receive treatments and will be followed at 12 weeks post final treatment.

Official Title
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This is an Exploratory Multi-center, Pilot Study to Evaluate the Safety, Efficacy and Ergonomics of Cutera truSculpt Device. Subjects May Receive up to Three Treatments and Will be Followed at 12 Weeks Post the First and Final Treatment.

Conditions
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Bulging, Body Fat

Intervention / Treatment
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* Device: truSculpt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be able to read, understand and sign the Informed Consent Form. Female or Male, 18 to 65 years of age (inclusive). Subject has visible fat bulges in the area to be treated. Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study. Subject must agree to not undergo any other procedure(s) in the treatment region during the study period. 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. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, (educational and/or marketing), publications, and any additional marketing purposes. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study. Exclusion Criteria: Participation in a clinical trial of another device or drug within 3 months 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. 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: truSculpt<br>truSculpt treatment | Device: truSculpt<br>* Subjects will receive utreatments and will be followed at 12 weeks post final treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Fat Assessment by Investigator | Degree of Improvement in body fat as assessed by Investigator using the Global Aesthetic Improvement Scale (GAIS:) +4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, and 0=No Change Higher scores indicate better outcomes | 12 weeks post final treatment |