NCT02271672

XP1000 RF Therapy on Waist Circumference Reduction

Effect of the XP1000 RF Therapy on Waist Circumference Reduction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: BTL Industries Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study was designed to demonstrate safety and efficacy of the XP1000 RF for non-invasive temporary reduction of waist circumference by disruption of adipocyte cells.

Detailed description

This study is a prospective, double-blinded, randomized, two-arm sham-controlled study of circumferential waist reduction following 4 treatment sessions delivered once a week over a 4-week period. The objective of the study is to demonstrate the effectiveness of the treatment after 30-day and 90-day Follow Up in achieving waist circumference reduction of ≥3 cm across the waist line relative to the base line assessment and their mean waist circumferential reduction is ≥1 cm than the average circumferential reduction of sham group.

Conditions

• Circumferential Reduction
• Waist Circumferential Reduction

Interventions

Type	Name	Description
DEVICE	XP1000 RF	Treatment of adipose tissue within the fat layer with XP1000 RF.
DEVICE	sham XP1000 RF	Treatment of adipose tissue within the fat layer with XP1000 RF.

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-03-01
• Completion: 2015-06-01
• First posted: 2014-10-22
• Last updated: 2015-06-18