Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT02271672
Study type Interventional
Source BTL Industries Ltd.
Contact
Status Completed
Phase N/A
Start date August 2014
Completion date June 2015

See also
  Status Clinical Trial Phase
Completed NCT02023385 - BTL-9000 Low Level Laser Therapy for the Waist Circumferential Reduction N/A
Completed NCT02023398 - BTL-9000 High Frequency 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