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

September 28, 2022 updated by: Alma Lasers

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Be'er Ya'aqov, Israel
        • Yitzhak Shamir Medical Center
  • United States
    • Florida
      • Boca Raton, Florida, United States, 33431
        • Sanctuary Plastic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser assisted liposuction
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
Abdominal/ Outer thighs Laser Assisted Liposuction. Five to twenty subjects out of the study group will also undergo facial fat grafting.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alma Lasers

Investigators

  • Principal Investigator: Jason N. Pozner, M.D., Sanctuary Plastic Surgery
  • Principal Investigator: Lior Heller, M.D., Yitzhak Shamir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2018

Primary Completion (Actual)

September 10, 2019

Study Completion (Actual)

May 20, 2020

Study Registration Dates

First Submitted

January 9, 2019

First Submitted That Met QC Criteria

January 9, 2019

First Posted (Actual)

January 11, 2019

Study Record Updates

Last Update Posted (Actual)

October 25, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • ALM-Lipo-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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