Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System

Study Overview
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Brief Summary
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Multi-center, prospective, open-label, single arm study. The study aims to evaluate the safety and efficacy of Laser Assisted Liposuction procedure performed with the LipoLife system. The study will include twenty (20) eligible subjects, that are willing to undergo abdominal or outer thighs laser-assisted liposuction. Five to twenty (5-20) subjects out of this study group should also be eligible for facial fat grafting. Follow up visits to evaluate study endpoints will take place at 1, 3 and 6 months after the surgery.

Official Title
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The Safety and Efficacy of Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System

Conditions
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Laser Assisted Liposuction

Intervention / Treatment
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* Device: LipoLife system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with excessive fat in the lower abdomen or subjects with excessive fat in the outer thighs that are willing to undergo laser-assisted liposuction Estimated fat harvesting of 1-3 liters Subjects (5-20) eligible for facial fat grafting of at least 5 cc for each cheek Between 18 and 70 years of age Provided written Informed Consent Exclusion Criteria: Body Mass Index (BMI) >35 Sever skin laxity Positive pregnancy test Current smoker Presence of known malignancy Active infection in the treatment area History of autoimmune disorder (e.g., Systemic Lupus Erythematosus [SLE]) History of connective, metabolic or atrophic skin disease History of keloid scarring Chronic use (>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days prior to enrollment Subjects with immune system diseases Subject unable to follow post-treatment instructions Any other reason that in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Laser assisted liposuction<br>Laser Assisted Liposuction with the LipoLife system. Each subject underwent laser assisted liposuction surgery w/wo facial fat grafting , using the LipoLifeTM system. Pre-surgery evaluation visit was carried out 1 week prior to the surgery. Follow up visits to evaluate safety and efficacy will take place at 1, 3 and 6 months after the surgery. | Device: LipoLife system<br>* Abdominal/ Outer thighs Laser Assisted Liposuction. Five to twenty subjects out of the study group will also undergo facial fat grafting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correct Identification of Before and After Photographs | Over 90% success in correct identification of before and after body contouring photos by blinded evaluators. | 3 months |