NCT05260164

Effect of BTL-899 Device for Non-invasive Lipolysis on Human Flanks

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: BTL Industries Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the clinical safety and the performance of the BTL-899 device (with its 899-AP-C-4 and 899-AP-C-5 applicators) during treatment of the flanks (also known as "love handles"). The study has a single-arm, open-label, interventional design. The subjects will be enrolled and assigned into one study arm and will be required to complete four (4) treatment visits. Both flanks will be treated simultaneously for 30 minutes per session. The flanks' fat thickness reduction will be documented by ultrasound. At the baseline visits health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed. The treatment administration phase consists of four (4) treatment visits, delivered 5 - 10 days apart. At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-899 device. Safety measures will include documentation of adverse events (AE) during and after the procedures. Follow-ups visits at 1 month and 3 months after the final treatment will be held.

Conditions

• Fat Burn

Interventions

Type	Name	Description
DEVICE	HIFEM+RF	Combination of High-Intensity Focused Electromagnetic Field (HIFEM) and a high radio frequency (RF) field.

Timeline

• Start date: 2022-03-11
• Primary completion: 2022-11-30
• Completion: 2023-01-30
• First posted: 2022-03-02
• Last updated: 2023-04-12

Locations

1 site across 1 country: Bulgaria