NCT04871503

High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Toning of Buttocks

Simultaneous Application of High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Toning of Buttocks

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: BTL Industries Ltd. · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the clinical efficacy and safety of the BTL-899 device for toning of buttocks. The study is a prospective multi-center open-label two-arm study. The subjects will be enrolled and assigned into two study groups. The subjects will be enrolled and assigned into two study groups; HIFEM+RF (HR) and HIFEM (H) group. Subjects of both groups will be required to complete four (4) treatment visits and two follow-up visits.

Conditions

• Muscle Tone

Interventions

Type	Name	Description
DEVICE	BTL-899 Buttocks	The treatment administration phase in both study groups will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899 will be applied over the gluteal area.

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-10-06
• Completion: 2022-01-12
• First posted: 2021-05-04
• Last updated: 2022-02-09

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study