NCT05519124

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: BTL Industries Ltd. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Wrinkle

Interventions

Type	Name	Description
DEVICE	BTL-785-7	Treatment with the BTL-785-7 applicator to the BTL-785F system.

Timeline

• Start date: 2021-11-03
• Primary completion: 2022-04-30
• Completion: 2022-06-22
• First posted: 2022-08-29
• Last updated: 2022-08-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study