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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Fat Burn

Clinical Trial Details

NCT number	NCT05260164
Study type	Interventional
Source	BTL Industries Ltd.
Contact
Status	Completed
Phase	N/A
Start date	March 11, 2022
Completion date	January 30, 2023

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