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BTL-785F Device for Non-invasive Reduction of Wrinkles

Wrinkle Clinical Trial

Official title:
Evaluation of Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Wrinkles

Clinical Trial Summary

This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive treatment of facial wrinkles. The study is a multicenter single-arm, open-label, interventional study.

Clinical Trial Description

This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive treatment of facial wrinkles. The study is a multicenter single-arm, open-label, interventional study. The subjects will be enrolled and assigned into one experimental study arm. The subjects will be required to complete four (4) treatment visits and two follow-up visits. At the baseline visit 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. Safety measures will include documentation of adverse events (AE) including the subject's experience of pain or discomfort after the procedure. Occurrence of AE's will be checked immediately after the first treatment visit, prior/post to the every other procedure and at the follow-ups. Subjects will undergo two follow-up visits scheduled at 1 month and 3 months after the final treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05519124
Study type Interventional
Source BTL Industries Ltd.
Contact
Status Completed
Phase N/A
Start date November 3, 2021
Completion date June 22, 2022
View Details
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