NCT03756168

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

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

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

Summary

The objective of this clinical study is to assess the safety and efficacy of using a 1060 nm diode laser for non-invasive fat reduction of the flanks.

Detailed description

Open-label, baseline-controlled, evaluator-blind, multi-center study evaluating a 1060 nm diode laser for non-invasive fat reduction of the flanks. The study will enroll up to 50 subjects requesting non-invasive lipolysis of the flanks. Each subject will receive a single study treatment. Subjects will be followed at six weeks and twelve weeks post-treatment. Twelve week outcome will be compared to baseline.

Conditions

• Fat Atrophy

Interventions

Type	Name	Description
DEVICE	1060nm Diode laser	All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks Venus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment 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: 2024-01-30
• Results posted: 2024-01-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study