NCT02023398

BTL-9000 High Frequency Therapy for the Waist Circumferential Reduction

Evaluation of the Effectiveness of the BTL-9000 High Frequency Therapy for the Waist Circumferential Reduction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (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 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.

Detailed 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.

Conditions

• Circumferential Reduction
• Waist Circumferential Reduction

Interventions

Type	Name	Description
DEVICE	BTL-9000 HFT	Deep tissue heating with the BTL-9000 HFT for HFT group
DEVICE	sham BTL-9000 HFT	sham deep tissue heating with BTL-9000 HFT in Placebo group

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

Locations

1 site across 1 country: Slovakia