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

NCT05260164 NA COMPLETED

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.

Details

Lead sponsor	BTL Industries Ltd.
Phase	NA
Status	COMPLETED
Enrolment	55
Start date	Fri Mar 11 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Jan 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Fat Burn

Interventions

• HIFEM+RF

Countries

Bulgaria