NCT04587986

rPMS and Radiofrequency for Abdominal Toning and Reduction of Subcutaneous Fat

Efficacy of Simultaneous Application of Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) and Radiofrequency for Abdominal Toning and Reduction of Subcutaneous Fat: Single-Blind Randomized Sham-Controlled Trial

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

Summary

This study will evaluate the clinical efficacy and safety of a simultaneous treatment by high power magnet and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. The study is a prospective multi-center single-blinded sham-controlled study. The subjects will be enrolled and assigned into two study groups; active and sham group. Subjects of both groups will be required to complete three (3) treatment visits and two to three follow-up visits.

Detailed description

This study will evaluate the clinical efficacy and safety of a simultaneous treatment by high power magnet and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. The study is a prospective multi-center single-blinded sham-controlled study. The subjects will be enrolled and assigned into two study groups; active and sham group. Subjects of both groups will be required to complete three (3) treatment visits and two to three follow-up visits. At the baseline visit, ultrasound imaging will be performed; the subject's weight and waist circumference will be recorded. Photos of the treated area will be taken. The treatment administration phase in both study groups will consist of three (3) treatments, delivered once a week. The applicator of BTL-703 will be applied over the umbilicus. The active group will receive treatment with intensities of a magnetic field and radiofrequency energy just below the patient's tolerance threshold. The device will induce visible muscle contractions along with heating of the subcutaneous fat. The sham group will receive a treatment with the intensities of the magnetic field and radiofrequency energy set to 5% of the maximum device output. 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 the 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 ultrasound imaging. Also, the 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.

Conditions

• Fat Burn

Interventions

Type	Name	Description
DEVICE	BTL-899	Treatment with intensities of a magnetic field and radiofrequency energy just below the patient's tolerance threshold.

Timeline

• Start date: 2019-07-30
• Primary completion: 2020-06-16
• Completion: 2021-03-16
• First posted: 2020-10-14
• Last updated: 2021-04-01

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study