NCT03545633

Changes in Abdominal Tissues Induced by Magnetic Device - MRI Evaluation

Safety and Efficacy of Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) for Fat Disruption of the Abdomen

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: BTL Industries Ltd. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

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 three follow-up visits, 2 months, 6 and 12 months after the final treatment. At the baseline visit photographs of the abdomen will be taken. In addition, adipose/muscle layer thickness will be measured with the magnetic resonance imaging and the subject's weight will be recorded. Safety measures will include documentation of adverse events (AE) including subject's experience of pain or discomfort after the procedure. Following each treatment administration and at the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment. In addition, at the last therapy visit, subjects will receive Subject Satisfaction and Therapy Comfort Questionnaires to fill in. Post-procedure evaluation (follow-up visits) will be conducted 2, 6 and 12 months after the final treatment. During those visits, magnetic resonance imaging, photographing and weight measure will be conducted. Subject Satisfaction Questionnaire will be given at every follow-up visit.

Conditions

• Fat Burn

Interventions

Type	Name	Description
DEVICE	Treatment with High Intensity Focused ElectroMagnetic system.	The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the abdomen area. Visible contractions will be induced by the device.

Timeline

• Start date: 2017-12-15
• Primary completion: 2019-05-15
• Completion: 2019-06-15
• First posted: 2018-06-04
• Last updated: 2020-09-14

Locations

2 sites across 2 countries: United States, Bulgaria

Regulatory

• FDA-regulated device study