An interventional study of BTL-9000 LLLT and sham BTL-9000 LLLT in Circumferential Reduction and Waist Circumferential Reduction, sponsored by BTL Industries Ltd.. Completed. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-19.
Sponsored by BTL Industries Ltd. · Not applicable, Interventional, and Treatment
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.
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.
BTL Industries Ltd. is the lead sponsor of 71 studies on the registry; 4 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Subjects 18-70 years of age of both gender with excess adipose tissue in the abdomen area
Exclusion Criteria:
Subjects in the Low Level Laser Therapy (LLLT) group will be treated with the BTL-9000 LLLT
Device: BTL-9000 LLLT
Subjects in the Placebo group with be treated with the sham BTL-9000 LLLT
Device: sham 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
Also known as: BTL-9000 LowLevel Laser Therapy
Irradiation of adipocyte cells within the fat layer with sham BTL-9000 LLLT for the release of fat and lipids from these cells
Waist Circumferential reduction
The subjects in the LLLT group whose average post-treatment waist circumference shows reduction of 3 cm or greater across the waistline relative to the base line assessment and their average waist circumferential reduction is 1 cm or greater than the average circumferential reduction of Placebo group are considered to meet the study primary outcome success criteria.
Time frame: 30 days follow up after 8 twice-a-week treatments
Adverse Events
Absence of adverse events (AE) associated with the treatment procedure. Safety evaluations of skin reaction in the treatment area would be conducted at every treatment and follow up visits
Time frame: 1 month follow up
No study locations are listed for this record.
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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BTL Industries Ltd.