NCT03800563

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Alma Lasers · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DEVICE	LipoLife system	Abdominal/ Outer thighs Laser Assisted Liposuction. Five to twenty subjects out of the study group will also undergo facial fat grafting.

Timeline

• Start date: 2018-11-06
• Primary completion: 2019-09-10
• Completion: 2020-05-20
• First posted: 2019-01-11
• Last updated: 2022-10-25
• Results posted: 2022-10-25

Locations

2 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated device study