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Abdomen - Fat Reduction and Muscle Toning

Fat Burn Clinical Trial

Official title:
Abdominal Treatment With Simultaneous Application of Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) and Radiofrequency

Clinical Trial Summary

This study will evaluate the clinical efficacy and safety of a simultaneous treatment by repetitive pulse magnetic stimulation and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. 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 three (3) treatment visits and two to three 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 a simultaneous treatment by repetitive pulse magnetic stimulation and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. 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 three (3) treatment visits and two to three follow-up visits. All of the study subjects will receive the treatment with the subject device. At the baseline visit MRI will be performed, subject's weight and waist circumference will be recorded. Photos of the treated area will be taken. The treatment administration phase will consist of three (3) treatments, delivered once a week. The applicator will be applied over umbilicus and visible muscle contractions along with heating of the subcutaneous fat will be induced by the device. At the last therapy visit, the subject's weight and waist circumference will be recorded, and photos of the treated area will be taken. In addition, subjects will receive Subject Satisfaction Questionnaire to fill in. Safety measures will include documentation of adverse events (AE) including 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 MRI scanning. Also, subject's satisfaction will be noted and weight with waist circumference will be recorded. Photographs of the treated area will be taken. There will be an option of a 6-months follow-up visit, according to subject's availability. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04587804
Study type Interventional
Source BTL Industries Ltd.
Contact
Status Completed
Phase N/A
Start date June 17, 2019
Completion date March 15, 2021
View Details
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