An interventional study of BTL-9000 HFT and sham BTL-9000 HFT in Circumferential Reduction and Waist Circumferential Reduction, sponsored by BTL Industries Ltd.. Completed at 1 site in Slovakia. 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 HFT in achieving 3 cm or greater average waist circumferential reduction in HFT 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 HFT group of 64 subjects who are treated with the BTL-9000 HFT and the other arm is the Placebo group of 38 subjects treated with the sham device. The objective of the study is to demonstrate the effectiveness of the BTL-9000 HFT treatment in achieving average post-treatment waist circumference 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 77 studies on the registry; 5 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Subjects in the High Frequency Therapy (HFT) group will be treated with the BTL-9000 HFT
Device: BTL-9000 HFT
Subjects in the Placebo group with be treated with the sham BTL-9000 HFT
Device: sham BTL-9000 HFT
Deep tissue heating with the BTL-9000 HFT for HFT group
Also known as: BTL-9000 High Frequency Therapy
sham deep tissue heating with BTL-9000 HFT in Placebo group
Waist Circumference Reduction
The subjects in the HFT 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 mean 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: 1 month follow up after 5 once-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
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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