Histological Study to Assess Safety and Efficacy of the TempSure Firm 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 safety and efficacy data on the TempSure Firm. The intended use of the TempSure device is to use the Firm handpieces for non-invasive lipolysis.

Detailed Description
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Up to 12 subjects will be enrolled at up to 3 study centers. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive 1 treatment on the abdomen with the TempSure firm. Subjects will undergo abdominoplasty surgery at one of 4 predetermined timepoint after an abdomen treatment: day 0 (within 24 hours after treatment), 10 days (+/- 3 days), 20 days (+/- 3 days), or 30 days (+/- 7 days). This will be determined by the availability of the subject and/or an as needed basis and this will be decided by the Investigator and the Sponsor.

Official Title
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Histological Study to Assess Safety and Efficacy of the TempSure Firm for Non-Invasive Lipolysis

Conditions
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Non-invasive Lipolysis

Intervention / Treatment
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* Device: TempSure Firm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female between 18 - 55 years old. Willing to receive treatments with the TempSure® device and willing to have biopsies taken from a control site and the treatment area (biopsies are collected after the abdominal tissue flap is removed during abdominoplasty surgery) Understand and accept obligation not to receive any other procedures on the treatment and control areas throughout the length of the study. Understand and accept the obligation and able to be present for all study visits Willing to comply with all requirements of the study and able to provide informed consent. Exclusion Criteria: 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 to become pregnant prior to the end of the study. Currently enrolled in an investigational drug or device trial, or has received an investigational drug or investigational device treatment(s) in the area to be treated (or designated control area) 6 months prior to entering this study (or at the discretion of the Investigator) . Cuts, wounds, or infected skin on the area to be treated or designated control area On local, oral, or systemic anesthetic agents. Condition(s) or circumstance(s) that, in the investigators opinion, may put the subject at significant risk, may confound study results or may interfere significantly with subject participation.

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There are 4 different arms, each with different time frames based on thei subjects' availability. Each group uses the same device and treatment parameters, with the only difference being when follow up measures are taken.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TempSure Firm Day 0 Biopsy Group<br>Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 0 (within 24 hours after treatment). | Device: TempSure Firm<br>* The TempSure firm will be used on the abdomen for non-invasive lipolysis.<br>|
| Experimental: TempSure Firm Day 10 Biopsy Group<br>Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 10 (+/- 3 days) after treatment. | Device: TempSure Firm<br>* The TempSure firm will be used on the abdomen for non-invasive lipolysis.<br>|
| Experimental: TempSure Firm Day 20 Biopsy Group<br>Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 20 (+/- 3 days) after treatment. | Device: TempSure Firm<br>* The TempSure firm will be used on the abdomen for non-invasive lipolysis.<br>|
| Experimental: TempSure Firm Day 30 Biopsy Group<br>Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 30 (+/- 7 days) after treatment. | Device: TempSure Firm<br>* The TempSure firm will be used on the abdomen for non-invasive lipolysis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histology of Biopsy | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm within 24 hours post treatment. The samples were looked at from a qualitative standpoint to determine of whether the samples had signs of adipocyte injury and/or inflammatory tissue response, and if there was dermal/epidermal tissue injury (which was assessed by a qualified histologist). | within 24 hours post treatment | 
| Histology of Biopsy | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 10 (+/- 3 days) after treatment. The samples were looked at from a qualitative standpoint to determine of whether the samples had signs of adipocyte injury and/or inflammatory tissue response, and if there was dermal/epidermal tissue injury (which was assessed by a qualified histologist). | within 10 days (+/- 3 days) post treatment | 
| Histology of Biopsy | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 20 (+/- 3 days) after treatment. The samples were looked at from a qualitative standpoint to determine of whether the samples had signs of adipocyte injury and/or inflammatory tissue response, and if there was dermal/epidermal tissue injury (which was assessed by a qualified histologist). | within 20 days (+/- 3 days) post treatment | 
| Histology of Biopsy | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 30 (+/- 3 days) after treatment. The samples were looked at from a qualitative standpoint to determine of whether the samples had signs of adipocyte injury and/or inflammatory tissue response, and if there was dermal/epidermal tissue injury (which was assessed by a qualified histologist). | within 30 days (+/- 7 days) post treatment |