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

Not Applicable

Completed

• Conditions: Laser Assisted Liposuction
• Interventions: Device: LipoLife system

• Registration Number: NCT03800563
• Lead Sponsor: Alma Lasers

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-06
• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-09
• Study First Posted: 2019-01-11
• Primary Completion: 2019-09-10
• Status Verified: 2019-11
• Study Completion: 2020-05-20
• Results First Submitted: 2022-08-07
• Results First Submitted QC: 2022-09-28
• Last Update Submitted: 2022-09-28
• Results First Posted: 2022-10-25
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laser assisted liposuction	LipoLife system	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.

Primary Outcome Measures

Name	Time	Method
Correct Identification of Before and After Photographs	3 months	Over 90% success in correct identification of before and after body contouring photos by blinded evaluators.

Trial Locations

Locations (2)

Yitzhak Shamir Medical Center; 🇮🇱 Be'er Ya'aqov, Israel

Sanctuary Plastic Surgery; 🇺🇸 Boca Raton, Florida, United States