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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02023398
Study type Interventional
Source BTL Industries Ltd.
Contact
Status Completed
Phase N/A
Start date September 2013
Completion date December 2013

See also
  Status Clinical Trial Phase
Completed NCT02023385 - BTL-9000 Low Level Laser Therapy for the Waist Circumferential Reduction N/A
Completed NCT04406935 - Evaluation of the Safety and Efficacy of the NuEra Tight for Abdominal Circumference Reduction N/A
Completed NCT02271672 - XP1000 RF Therapy on Waist Circumference Reduction N/A