Clinical Evaluation of a 1060 nm Diode Laser, PEMF and Vacuum Assisted MP RF for Non-invasive Fat Reduction

Study Overview
=================
Brief Summary
-----------------
Open-label, baseline-controlled, multi-center study evaluating a 1060 nm diode laser, pulsed electromagnetic fields and vacuum assisted radio frequency for non-invasive fat reduction of the abdomen and flanks.

Detailed Description
-----------------
Open-label, baseline-controlled, multi-center study evaluating a 1060 nm diode laser, pulsed electromagnetic fields and vacuum assisted radio frequency for non-invasive fat reduction of the abdomen and flanks. The study will enroll up to 200 subjects requesting non-invasive lipolysis of the abdomen and flanks. Each subject will receive up to 4 study treatments of the diode laser and up to 8 treatments of the pulsed electromagnetic fields and vaccum assisted radio frequency study treatments. Subjects will be followed at twelve weeks post final diode treatment. Twelve week post treatment outcome will be compared to baseline.

Official Title
-----------------
Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser, Pulsed ElectroMagnetic Fields and Vacuum Assisted Multipolar Radio Frequency for Non-invasive Fat Reduction of the Abdomen and Flanks

Conditions
-----------------
Adipose Tissue Atrophy

Intervention / Treatment
-----------------
* Device: Venus Bliss


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Able to read, understand and voluntarily provide written informed consent. 2. Healthy male or female, ≥ 18 years of age seeking treatment for unwanted fat in the flanks. 3. BMI score is less than 35. 4. Agree to not making any major changes in their diet or lifestyle during the course of the study. 5. Able and willing to comply with the treatment/follow-up schedule and requirements. 6. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative Urine Pregnancy test at baseline. Exclusion Criteria: 1. Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 6 months. 2. Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months. 3. History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection) or use of immunosuppressive medications, 6 months prior to and during the course of the study. 4. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding. 5. Use of antiplatelet medications (81 mg acetylsalicylic acid daily permitted), anticoagulants, thrombolytics or anti-inflammatory medications within 2 weeks of treatment. 6. Having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions. 7. Having a permanent implant in the treatment area such as metal plates or an injected chemical substance such as silicone or parenteral gold therapy (gold sodium thiomalate). 8. Use of medications, herbs, food supplements, and vitamins known to induce photosensitivity to light exposure at the wavelength used or history of photosensitivity disorder. 9. 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. 10. Tattoos in the treatment area. 11. Poor skin quality (severe laxity). 12. Abdominal wall, muscular abnormality or hernia on physical examination. 13. Use of retinoids such as oral isotretinoin (Accutane™) within the past six months or during course of the study. 14. History of keloid or hypertrophic scar formation or poor wound healing in the treatment area. 15. As per the investigator's discretion, any physical or mental condition which may make it unsafe for the subject to participate. 16. Unable or unlikely to refrain from sun exposure, artificial tanning, including the use of tanning booths, prior to (six weeks) and during the course of the evaluation.

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
Interventional Model Description: Up to 200 subjects will be enrolled in the study to receive up to 4 Diode and up to 8 RF treatments. The Principal Investigator will determine the suitable number of treatments based on the subject treatment area.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subject treatment group<br>Treatment group receiving up to 4 diode treatments and up to 8 RF treatments. | Device: Venus Bliss<br>* The FDA cleared device (Venus Bliss™) is a non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060 nm diode laser applicators (60 mm x 60 mm). A belt is included to allow the operator to secure the laser applicators on the lipolysis treatment area, allowing hands free operation. The device uses vacuum assisted radiofrequency (RF) and PEMF (pulsed electromagnetic field) technology which has been shown in clinical studies to be safe and effective in body circumferential reduction and skin tightening.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photographic evaluation | Photographic evaluation by an independent, blinded reviewer with correct identification of pre-treatment baseline images when compared to post-treatment images taken at twelve weeks | week 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject satisfaction: 5-Point Likert Subject Satisfaction Scale | To assess subject satisfaction with treatment at twelve weeks using the 5-Point Likert Subject Satisfaction Scale. 0 = very dissatisfied, 2 = dissatisfied, 4 = neutral, 6 = neutral (no change), 8 satisfied, 10 very satisfied | week 30 | 
| Subject assessment of discomfort: Wong Baker scale | Subject's assessment of discomfort and pain post-treatment as measured by the Wong-Baker Faces Pain rating scale. Wong Baker scale 0 = no pain, 1-2 = mild pain, 3-4 = moderate pain, 5-6 = severe pain, 7-8 = very severe pain, 9-10 = worst pain imaginable. | week 1 | 

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