NCT03756350

Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser (Abdomen)

Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser for Non-invasive Fat Reduction of the Abdomen

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Venus Concept · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is evaluating a 1060nm diode laser for non-invasive fat reduction of the abdomen. The study will enrolled up to 50 subjects requesting non-invasive lipolysis of the abdomen. Each subject will receive a single study treatment. Subjects will be followed at six and twelve weeks post treatment. Twelve week outcomes will be compared to baseline.

Detailed description

Open-label baseline controlled evaluator-blind multi-centre study evaluating a 1060nm diode laser for non-invasive fat reduction of the abdomen. The study will enrolled up to 50 subjects requesting non-invasive lipolysis of the abdomen. Each subject will receive a single study treatment which takes approximately 25 minutes. Subjects will be followed at six and twelve weeks post treatment. Twelve week outcomes will be compared to baseline.

Conditions

• Fat Atrophy

Interventions

Type	Name	Description
DEVICE	1060nm diode laser	Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.

Timeline

• Start date: 2018-11-14
• Primary completion: 2019-07-02
• Completion: 2019-07-02
• First posted: 2018-11-28
• Last updated: 2023-07-03
• Results posted: 2023-07-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study