Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser, Pulsed ElectroMagnetic Fields and Vacuum Assisted Multipolar Radio Frequency for Non-invasive Fat Reduction of the Abdomen and Flanks

Status: Completed
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Open-label, baseline-controlled, multi-center study evaluating a 1060 nm diode laser, pulsed electromagnetic fields and vacuum assisted radio frequency for non-invasive fat reduction of the abdomen and flanks.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 1. Able to read, understand and voluntarily provide written informed consent. 2. Healthy male or female, ≥ 18 years of age seeking treatment for unwanted fat in the flanks.

⁃ BMI score is less than 35. 4. Agree to not making any major changes in their diet or lifestyle during the course of the study.

⁃ Able and willing to comply with the treatment/follow-up schedule and requirements.

⁃ Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative Urine Pregnancy test at baseline.

Locations
United States
California
Berman Skin Institute
Los Altos
Laser & Skin Surgery Medical Group, Inc
Sacramento
Batra Dermatology
Santa Monica
Illinois
aFresh Medispa
Chicago
Texas
UT Southwestern Medical Center Department of Plastic Surgery
Dallas
Time Frame
Start Date: 2019-09-19
Completion Date: 2022-10-22
Participants
Target number of participants: 39
Treatments
Experimental: Subject treatment group
Treatment group receiving 3 diode treatments and 3 RF/PEMF treatments at Week 0, 8 and 16 with a follow-up at Week 24.
Sponsors
Leads: Venus Concept

This content was sourced from clinicaltrials.gov