Histological Study on Safety and Efficacy of a RF Device Flexible Applicator for Non-Invasive Lipolysis

Study Overview
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Brief Summary
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This is a prospective, open-labeled, non-randomized, multi-center clinical study to collect efficacy data on the TempSure FlexSure applicator for fat lipolysis.

Detailed Description
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Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments every 1-2 weeks on the abdomen or flanks.

Official Title
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Histological Study to Assess Safety and Efficacy of a Radiofrequency Device Flexible Applicator for Non-Invasive Lipolysis

Conditions
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Lipolysis

Intervention / Treatment
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* Device: Non-Invasive Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A healthy male or female between the age of 18 - 55 years old. Willing to receive treatments with the TempSure device and are willing to have biopsies taken from a control site and the treatment area. Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study. Understands and accepts the obligation and is logistically able to be present for all visits. Is willing to comply with all requirements of the study and sign the informed consent document. Exclusion Criteria: Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study. The subject is currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months prior to entering this study. The subject has a cut, wound, or infected skin on the area to be treated. The subject is on local, oral, or systemic anesthetic agents. The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation. The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Experimental: FlexSure Applicator<br>The TempSure FlexSure applicator will be used on the abdomen or flanks. | Device: Non-Invasive Treatment<br>* Single-arm group using the FlexSure Applicator device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Count of Samples That Showed a Change in Adipocyte Necrosis After Treatment | Photographs of the histological samples before and after the treatment (only one treatment occurred) will be examined for adipocyte necrosis. Each specimen will first be preserved with a fixative and stained with Hematoxylin and eosin (H&E stain). To determine whether or not the samples are expressing histological changes, a pathologist will look at the histology of each individual sample and record if they see any changes in histology post treatment vs. the histology taken at the baseline (these changes are observable to the eye). Then, the number of biopsy samples that express any change in adipocyte necrosis will be reported. | immediately post treatment (only 1 treatment was conducted) | 
| Count of Samples That Showed an Inflammatory Immune Response Vs. Baseline | Photographs of the histological samples before and after the last treatment will be examined for an inflammatory immune response. Each specimen will first be preserved with a fixative and stained with Hematoxylin and eosin (H&E stain) To determine whether or not the samples are expressing histological changes, a pathologist will look at the histology of each individual sample and record if they see any changes in histology post treatment vs. the histology taken at the baseline (these changes are observable to the eye). Then, the number of biopsy samples that express any change in an inflammatory immune response will be reported. | Baseline, immediately post treatment (only 1 treatment was conducted) |