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

Completed · Not applicable

Conditions studied: Laser Assisted Liposuction

In brief

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.

Key facts

Study ID

NCT03800563

Run by

Alma Lasers

People needed

20

Starts

2018-11-06

Expected to finish

2020-05-20

Last updated by the study team

2022-10-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Sanctuary Plastic Surgery — Boca Raton, Florida, United States
• Yitzhak Shamir Medical Center — Be’er Ya‘aqov, Israel

Full record on ClinicalTrials.gov

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