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

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ClinicalTrials.gov Identifier: NCT03800563
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Laser Assisted Liposuction Device: LipoLife system Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Laser assisted liposuction
Laser Assisted Liposuction with the LipoLife system.
Device: LipoLife system
Abdominal/ Outer thighs Laser Assisted Liposuction. Five to twenty subjects out of the study group will also undergo facial fat grafting.




Primary Outcome Measures :
  1. Blinded comparison of before and after photographs [ Time Frame: 3 months ]
    Improvement in aesthetic appearance as determined by blinded comparison of before and after photographs.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800563


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

Locations
United States, Florida
Sanctuary Plastic Surgery Recruiting
Boca Raton, Florida, United States, 33431
Contact: Jason Pozner, M.D.    561-367-9101    drpozner@spsboca.com   
Israel
Yitzhak Shamir Medical Center Recruiting
Be'er Ya'aqov, Israel
Contact: Lior Heller, M.D.    +972-8-9778354    plastic@asaf.health.gov.il   
Sponsors and Collaborators
Alma Lasers
Investigators
Principal Investigator: Jason N. Pozner, M.D. Sanctuary Plastic Surgery
Principal Investigator: Lior Heller, M.D. Yitzhak Shamir Medical Center

Responsible Party: Alma Lasers
ClinicalTrials.gov Identifier: NCT03800563     History of Changes
Other Study ID Numbers: ALM-Lipo-002
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No