NCT03545646

Changes in Abdominal Tissues Induced by Magnetic Device - CT 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• Status: Withdrawn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 four follow-up visits, 1 month, 3, 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 computed tomography and the subject's weight will be recorded. In addition, at the last therapy visit, subjects will receive Subject Satisfaction and Therapy Comfort Questionnaires to fill in. 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. Post-procedure evaluation (follow-up visits) will be conducted 1 month, 3, 6 and 12 months after the final treatment. Computed tomography and weight measure will be conducted at every follow-up visit. Also, subject's satisfaction will be noted. During the first (1 month), third (6 months) and last (12 months) follow-up visits, photographs of abdomen will be taken.

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 1 country: United States

Regulatory

• FDA-regulated device study