Clinical Trials Logo

Clinical Trial Summary

This study will evaluate the clinical efficacy and safety of the BTL-899 device for changes in subcutaneous fat tissue and muscle tissue of arms. The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the subject device.


Clinical Trial Description

This study will evaluate the clinical efficacy and safety of the BTL-899 device for changes in subcutaneous fat tissue and muscle tissue of arms. The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the subject device. At the baseline visit, MRI imaging will be performed; the subject's weight and arm circumference will be recorded. Photos of the treated area will be taken. The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicator of BTL-899 will be applied over the treatment area. The device will induce visible muscle contractions along with heating of the subcutaneous fat. Each therapy session will last 30 minutes. At the last therapy visit, the subject's weight and arm circumference will be recorded, and photos of the treated area will be taken. In addition, subjects will receive a Subject Satisfaction Questionnaire to fill in. Safety measures will include documentation of adverse events (AE), including the subject's experience of pain or discomfort after each procedure. Following each treatment administration and at all of the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment. During the post-procedure visits (at 1-month and 3-month follow-up visits), the subjects will undergo a MRI imaging. Also, the subject's satisfaction will be noted, and weight with arm circumference will be recorded. Photographs of the treated area will be taken. In addition, subjects will receive a Lifestyle Change Questionnaire to fill in. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04596241
Study type Interventional
Source BTL Industries Ltd.
Contact
Status Completed
Phase N/A
Start date October 5, 2020
Completion date February 10, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05539716 - Metabolism and Sleep Apnea Treatment N/A
Completed NCT03219125 - Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women
Completed NCT04596228 - Non-invasive Lipolysis and Improvement of Muscle Tone in Inner Thighs N/A
Completed NCT03038620 - Impact of Liraglutide 3.0 on Body Fat Distribution Phase 4
Completed NCT00762307 - Non-invasive Cooling of Subcutaneous Fat N/A
Completed NCT02999763 - SlimShape Device for Abdominal Fat and Circumference Reduction N/A
Completed NCT05020054 - Effect of Tecartherapy in the Treatment of Localized Fat and Sagging Abdominal Skin - Clinical and Experimental Study N/A
Completed NCT03898830 - Eon™ FR Clinical Study Protocol 1064 N/A