Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser (Abdomen)

Study Overview
=================
Brief Summary
-----------------
This study is evaluating a 1060nm diode laser for non-invasive fat reduction of the abdomen. The study will enrolled up to 50 subjects requesting non-invasive lipolysis of the abdomen. Each subject will receive a single study treatment. Subjects will be followed at six and twelve weeks post treatment. Twelve week outcomes will be compared to baseline.

Detailed Description
-----------------
Open-label baseline controlled evaluator-blind multi-centre study evaluating a 1060nm diode laser for non-invasive fat reduction of the abdomen. The study will enrolled up to 50 subjects requesting non-invasive lipolysis of the abdomen. Each subject will receive a single study treatment which takes approximately 25 minutes. Subjects will be followed at six and twelve weeks post treatment. Twelve week outcomes will be compared to baseline.

Official Title
-----------------
Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser for Non-invasive Fat Reduction of the Abdomen

Conditions
-----------------
Fat Atrophy

Intervention / Treatment
-----------------
* Device: 1060nm diode laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: able to read, understand and voluntarily provide written informed consent healthy male or female > 18 years of age seeking treatment for unwanted fat in the abdomen BMI score is less then 30 agree to not making any major changes in their diet or lifestyle during the course of the study able and willing to comply with the treatment / follow up schedule and requirements women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrolment and for the duration of the study, have a negative urine pregnancy test baseline Exclusion Criteria: pregnant in the last 3 months intending to become pregnant, postpartum or nursing in the last 6 months any previous liposuction / lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months history of immunosuppression / immune deficiency disorders including AIDS and HIV infection, or use of immunosuppressive medications, 6 month prior to and during the course of the study History of hyperlipidemia, diabetes, hepatitis, blood coagulopathy or excessive bleeding Use of antiplatelet medications (81 mg of acetylsalicylic acid daily is permitted), anticoagulants, thrombocytes or any-inflammatory medications within 2 weeks of treatment Having a history of skin cancer or any other cancer in the area to be treated, including presence of malignant or pre-malignant pigmented lesions Having a permanent implant in the treatment area such as a metal plate or injected chemical substance such as silicone pr parenteral gold therapy (gold sodium thiomalate) Use of medications, herbs or food supplements and vitamins known to induce photosensitivity to light exposure at the wavelength used history of photosensitivity disorder Suffering from significant skin conditions in the treatment area or inflammatory skin conditions including but not limited to open lacerations, abrasions, herpes sores, cold sores, active infections Tattoos in the treatment area Poor quality skin (laxity) Abdominal wall, muscular abnormality or hernia on physical examination Unstable weight within the last 6 months (+ or - 3% weight change in the prior six months) Participation in another clinical study involving the same anatomical areas within the last 6 months History of keloid and hypertrophic scar formation or poor wound healing in the treatment area As per the investigators discretion any physician or mental condition which may make it unsafe for the subject to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment subjects<br>Single group of subjects which will have the treatment of a 1060nm diode laser administered to them. | Device: 1060nm diode laser<br>* Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Before and After Photograph Sets Correctly Identified by Independent, Blinded Evaluators | Photographic evaluation by independent blinded evaluators with correct identification of pre-treatment baseline images when compared to post-treatment images taken at 12 weeks | Week 12 vs baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fat Thickness | Change in thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline | week 12 | 
| Subject Satisfaction | Subject satisfaction with treatment at 12 weeks after treatment using the 5-point Likert Subject Satisfaction Scale. A score of 4 is very satisfied and 0 is very unsatisfied. | Week 12 | 
| Treatment Pain | Subject assessment of discomfort and pain post treatment as measured using the Wong Baker Faces Scale, which is a 10 point scale with 10 being the worst pain ever and 0 being no pain. | Week 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abdomen, adipose, fat