Evaluation of the Safety and Precursors of Efficacy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate and compare the safety and pre-cursors of efficacy of a non-invasive 1064nm laser and 940nm diode, for the disruption of subcutaneous adipose tissue and skin tightening.

Detailed Description
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The purpose of the biopsies is to assess if the device causes an inflammatory response in the abdominoplasty tissue that will be excised.

Official Title
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Evaluation of the Safety and Efficacy of a Non-Invasive Disruption of Fat and Skin Tightening Using 1064nm and 940nm Wavelengths

Conditions
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Subcutaneous Fat

Intervention / Treatment
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* Device: 1064nm Laser
* Device: 940nm Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-smoking subjects between ages of 20-55 years of age presenting excess abdominal tissue (fat and skin), are candidates for an abdominoplasty procedure and are willing to allow the use of this device on their skin Subjects (Group 2 and 3) who will allow the excess skin removed as part of the abdominoplasty to be sent for laboratory analysis Understand and accept the obligation associated with the procedure Subjects with Fitzpatrick skin types I to VI. Subjects (Group 2 and 3) who are willing to consent to participate in the study will be asked to undergo treatment, elasticity and ultrasound measurements, as outlined for each group and defined in section 6.0. Subjects must agree to maintain the same diet and exercise regime throughout the study Exclusion Criteria: Any previous liposuction/lipo-sculpture or any type of procedure in the abdominal area in the past 6 months A history of allergic reactions to medications or anesthesia required for the procedure A history of thrombophlebitis A history of acute infections A history of heart failure Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti-inflammatories within 2 weeks pre treatment Intolerance to anesthesia or medications to be prescribed before or after the procedure. Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study Taking medications that are photosensitive A history of keloid formation A study subject must not be pregnant or have been pregnant in the last 3 months The physician has the right to make determination of eligibility as he/she determines based on the standard of care

Ages Eligible for Study
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Minimum Age: 20 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: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1064nm laser Treatment Before Abdominoplasty<br>Patient will be treated with 1064nm Laser prior to abdominoplasty | Device: 1064nm Laser<br>* Patient will be treated with 1064nm Laser prior to abdominoplasty<br>|
| Experimental: 940nm Laser Treatment Before Abdominoplasty<br>Patient will be treated with 940nm Laser prior to abdominoplasty | Device: 940nm Laser<br>* Patient will be treated with 940nm Laser prior to abdominoplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biopsy of Tissue Sample as a Measure of Effectiveness | Biopsy of treated area will be obtained up to 6 months post treatment and will be histologically assessed for changes in adipocytes, collagen and surrounding tissue to determine effectiveness of device | 6 months post treatment | 
| Ultrasound Measurement to Evaluate Reduction of Fat | Ultrasound of the treatment area will be performed and evaluated in comparison to the baseline results to determine reduction of fat | 6 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High Frequency Ultrasound to Measure Skin Elasticity and Thickness | High frequency ultrasound of the treatment area will be performed and evaluated in comparison to baseline results to measure changes in skin elasticity and skin thickness. | 6 months post last treatment |