Long-term Follow-up Study of the truSculpt Radiofrequency Device for Circumferential Reduction

Study Overview
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Brief Summary
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A long-term follow-up study to evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for circumferential reduction.

Detailed Description
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The purpose of this investigation is to follow-up subjects who have completed participation in the Treatment Group of Protocol C-16-TS11 - Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction for the long-term (18 months) safety and efficacy of the truSculpt radiofrequency (RF) device for circumferential reduction in the abdominal and flank region.

Official Title
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Long-term Follow-up Study of the truSculpt Radiofrequency Device for Circumferential Reduction: 18-month Circumference Measuing of Some C-16-TS11 Subjects.

Conditions
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Abdominal Fat

Intervention / Treatment
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* Device: truSculpt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completed participation in the Treatment Group of Protocol C-16-TS11 - Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction Subject has maintained the same weight since enrolling in Protocol C-16-TS11 - Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction, within 5% of baseline weight measurement. Exclusion Criteria: Participation in a clinical trial of another device or drug in the target area since enrolling in Protocol C-16-TS11 - Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction. Any type of cosmetic treatment to the target area to reduce circumference since enrolling in Protocol C-16-TS11 - Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction e.g., radiofrequency, cryolysis or light-based treatments. Any invasive cosmetic surgery to the target area, such as liposuction, since enrolling in Protocol C-16-TS11 - Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction. Newly diagnosed (since enrolling in Protocol C-16-TS11) significant concurrent illness, such as diabetes mellitus, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders. Newly diagnosed or documented (since enrolling in Protocol C-16-TS11) immune system disorders. Current infection, dermatitis, rash or other skin abnormality in the treatment area. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or treatment in the target area since enrolling in Protocol C-16-TS11 - Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction. Pregnant or currently breastfeeding. As per the Investigator's discretion, any physical or mental condition which might make unsafe for the subject to participate in this study.

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 60 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| truSculpt<br>truSculpt effectiveness after 18 months | Device: truSculpt<br>* Device comparison of Circumference measurement at Baseline vs 18 months post treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circumference Measurement | Comparison of Abdominal region Measurement in cm 18 months post-treatment with C-16 TS11 Baseline. | 18 months post C-16-TS11 completion (September, 2016) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Safety | Measurement of Resolved Adverse Events from Radiofrequency (RF) treatment (C-16-TS11), and Presence of any Additional AE within 18 months of RF treatment. | 18 months post C-16-TS11 completion (September, 2016) |