NCT02023385

BTL-9000 Low Level Laser Therapy for the Waist Circumferential Reduction

Evaluation of the BTL-9000 Low Level Laser Therapy for the Waist Circumferential Reduction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: BTL Industries Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Prospective, two-arm, randomized study of the effectiveness of the BTL-9000 LLLT in achieving 3 cm or greater average waist circumferential reduction in LLLT group of subjects relative to the base line and 1 cm or greater reduction relative to the average waist circumferential reduction of the Placebo group.

Detailed description

Prospective, randomized, blinded, two-arms study of waist circumferential reduction following 5 once-a-week treatments. One arm is the LLLT group of 25 subjects who are treated with the BTL-9000 LLLT and the other arm is the Placebo group of 15 subjects treated with the sham device. The objective of the study is to demonstrate the effectiveness of the BTL-9000 LLLT treatment in achieving average post-treatment waist circumferential reduction of 3 cm or greater across the waistline relative to the baseline assessment and of 1 cm or greater than the average waist circumferential reduction of the Placebo group.

Conditions

• Circumferential Reduction
• Waist Circumferential Reduction

Interventions

Type	Name	Description
DEVICE	BTL-9000 LLLT	Irradiation of adipocyte cells within the fat layer with BTL-9000 LLLT for the release of fat and lipids from these cells
DEVICE	sham BTL-9000 LLLT	Irradiation of adipocyte cells within the fat layer with sham BTL-9000 LLLT for the release of fat and lipids from these cells

Timeline

• Start date: 2013-09-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-12-30
• Last updated: 2014-09-19