NCT03575507

Non-invasive Improvement of Buttocks With Magnetic Device

Safety and Patient Satisfaction With Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) for Aesthetic Improvements of Buttocks

• Status: Withdrawn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

Summary

This study will evaluate the clinical safety and patient satisfaction with the high power magnet system for the aesthetic improvement of buttocks. 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 - 1 month, 3 months and 12 months after the final treatment. Study will be conducted at several study sites. At the baseline visit, subject's weight will be recorded. The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the gluteal area. Visible contractions will be induced by the device. At the last therapy visit, the subject's weight will be recorded. 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 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 months and 12 months after the final treatment. A weight measure will be conducted. Also, subject's satisfaction will be noted.

Conditions

• Muscle Tightness

Interventions

Type	Name	Description
DEVICE	Treatment with BTL EMSCULPT device.	The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the buttock area. Visible contractions will be induced by the device.

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-09-30
• Completion: 2020-05-20
• First posted: 2018-07-02
• Last updated: 2020-05-27

Locations

2 sites across 2 countries: United States, Bulgaria

Regulatory

• FDA-regulated device study