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

NCT ID: NCT03800563

Last Updated: 2022-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-06
• Study Completion Date: 2020-05-20

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

LipoLife system

Intervention Type: DEVICE

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

Interventions

LipoLife system

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alma Lasers

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason N. Pozner, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sanctuary Plastic Surgery

Lior Heller, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yitzhak Shamir Medical Center

Locations

Sanctuary Plastic Surgery

Boca Raton, Florida, United States

Yitzhak Shamir Medical Center

Be’er Ya‘aqov, , Israel

Countries

United States; Israel

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

ALM-Lipo-002

Identifier Type: -

Identifier Source: org_study_id