NCT04090853

Subject Evaluation of a 1064nm Diode Laser/RF

Subject Evaluation of the Efficacy of a 1064 nm Diode Laser, Pulsed Electro-Magnetic Fields and Vacuum Assisted Multipolar Radio Frequency for Non-invasive Contouring of the Abdomen and Flanks

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Venus Concept · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Open-label, baseline-controlled, multi-center study evaluating a 1064 nm diode laser, pulsed electromagnetic fields and vacuum assisted radio frequency for non-invasive fat reduction of the abdomen and flanks.

Detailed description

The study will enroll up to 200 subjects requesting non-invasive lipolysis of the abdomen and flanks. Each subject will receive up to 3 study treatments of the diode laser and up to 3 treatments of the pulsed electromagnetic fields and vacuum assisted radio frequency study treatments. Subjects will be followed at 24 weeks post diode treatments to observe their satisfaction with treatment outcomes.

Conditions

• Subcutaneous Fat Disorder

Interventions

Type	Name	Description
DEVICE	Venus Bliss	The investigational device (Venus Bliss™) is a non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1064 nm diode laser applicators (60 mm x 60 mm). A belt is included to allow the operator to secure the laser applicators on the lipolysis treatment area, allowing hands free operation. The device uses vacuum assisted radiofrequency (RF) and PEMF (pulsed electromagnetic field) technology which has been shown in clinical studies to be safe and effective in body circumferential reduction and skin tightening.

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-07-08
• Completion: 2020-07-08
• First posted: 2019-09-16
• Last updated: 2023-05-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study