NCT05524740

BTL-785F Device for Improving the Structure of Facial Muscles

Evaluation of Safety and Efficacy of the BTL-785F Device for Improving the Structure of Facial Muscles

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (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 facial remodeling and investigate its effect on muscles and wrinkles.

Detailed description

The study is a single-center, single-arm, open-label, interventional study. The subjects will be enrolled and assigned into a single 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 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-785F device with the BTL-785-7 applicator for improvement of the structure of facial muscles.

Timeline

• Start date: 2022-06-27
• Primary completion: 2022-12-10
• Completion: 2023-05-23
• First posted: 2022-09-01
• Last updated: 2024-07-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study