Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System
NCT03800563 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2022-10-25
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
Interventions
- DEVICE
-
LipoLife system
Abdominal/ Outer thighs Laser Assisted Liposuction. Five to twenty subjects out of the study group will also undergo facial fat grafting.
Sponsors & Collaborators
-
Alma Lasers
lead INDUSTRY
Principal Investigators
-
Jason N. Pozner, M.D. · Sanctuary Plastic Surgery
-
Lior Heller, M.D. · Yitzhak Shamir Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-11-06
- Primary Completion
- 2019-09-10
- Completion
- 2020-05-20
- FDA Device
- Yes
Countries
- United States
- Israel
Study Locations
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