NCT05540080

Non-invasive Lipolysis and Improvement of Muscle Tone in Lateral Abdomen

Simultaneous Application of High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Non-invasive Lipolysis and Improvement of Muscle Tone in Lateral Abdomen

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: BTL Industries Ltd. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the clinical efficacy and performance of the BTL-899 device for changes in subcutaneous fat and muscle tissue in the lateral abdomen region (also referred to as flanks or "love handles"). 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 two follow-up visits. All of the study subjects will receive the treatment with the subject device.

Detailed description

At the baseline visit, MRI imaging will be performed; the subject's weight and waist circumference will be recorded. Digital photographs of the treated area will be taken. The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899 will be applied over the area of flanks. The device will induce visible muscle contractions along with heating of the subcutaneous fat. Each therapy session will last 30 minutes. At the last therapy visit, the subject's weight and waist circumference will be recorded, and digital photographs of the treated area will be taken. In addition, subjects will receive Therapy Comfort and Subject Satisfaction Questionnaire to fill in. Safety measures will include documentation of adverse events (AE), which will be assessed after each procedure and at all of the follow-up visits.

Conditions

• Fat Burn

Interventions

Type	Name	Description
DEVICE	BTL-899	Treatment with applicators C4/C5 to the BTL-899 system.

Timeline

• Start date: 2022-06-10
• Primary completion: 2023-01-10
• Completion: 2023-10-11
• First posted: 2022-09-14
• Last updated: 2024-04-26

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study