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

NCT03800563 | Completed Results FDA Device

• 1 other identifier: ALM-Lipo-002
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 2

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.

Conditions

Laser Assisted Liposuction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Laser assisted liposuction

EXPERIMENTAL

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

Interventions

LipoLife system DEVICE

Abdominal/ Outer thighs Laser Assisted Liposuction. Five to twenty subjects out of the study group will also undergo facial fat grafting.

Laser assisted liposuction

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Alma Lasers: lead

Study Sites (2)

Sanctuary Plastic Surgery

Boca Raton, Florida, 33431, United States

Location

Yitzhak Shamir Medical Center

Be’er Ya‘aqov, Israel

Location

Results Point of Contact

• Title: Dr Meital Grafi-Cohen
• Organization: Alma Lasers

meital.grafi@almalasers.co.il

+972-523708780

Study Officials

• Jason N. Pozner, M.D.

  Sanctuary Plastic Surgery

  PRINCIPAL INVESTIGATOR

• Lior Heller, M.D.

  Yitzhak Shamir Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 11, 2019
• Study Start: November 6, 2018
• Primary Completion: September 10, 2019
• Study Completion: May 20, 2020
• Last Updated: October 25, 2022
• Results First Posted: October 25, 2022

Record last verified: 2019-11

Locations

US (1); IL (1)