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

Laser Assisted Liposuction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03800563
• Other study ID #: ALM-Lipo-002
• Status: Completed
• Phase: N/A
• Start date: November 6, 2018
• Est. completion date: May 20, 2020

Study information

• Verified date: November 2019
• Source: Alma Lasers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 20, 2020
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laser Assisted Liposuction

Intervention

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

Locations

Country	Name	City	State
Israel	Yitzhak Shamir Medical Center	Be'er Ya'aqov
United States	Sanctuary Plastic Surgery	Boca Raton	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alma Lasers

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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