Boca Raton, Florida 33431


Purpose:

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.


Criteria:

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.


NCT ID:

NCT03800563


Primary Contact:

Principal Investigator
Jason N. Pozner, M.D.
Sanctuary Plastic Surgery

Jason N. Pozner, M.D.
Phone: 561-367-9101
Email: drpozner@spsboca.com


Backup Contact:

N/A


Location Contact:

Boca Raton, Florida 33431
United States

Jason Pozner, M.D.
Phone: 561-367-9101
Email: drpozner@spsboca.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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