NCT04447963

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: 51 (actual)
• Sponsor: BTL Industries Ltd. · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with BTL-785-2 applicator for non-invasive treatment of facial wrinkles.

Detailed description

This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with BTL-785-2 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 three (3) treatment visits and two follow-up visits. 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-785F device. Safety measures will include documentation of adverse events (AE) during and after the procedures. Follow-ups visits at 3 months and 6 months after the final treatment will be held.

Conditions

• Wrinkle

Interventions

Type	Name	Description
DEVICE	Non-invasive treatment of facial wrinkles	Application of radiofrequency field which provides controlled heating to the skin.Therapeutic effect is observed when the tissue temperature reaches 40-45 degrees Celsius.

Timeline

• Start date: 2020-06-15
• Primary completion: 2021-03-31
• Completion: 2021-06-28
• First posted: 2020-06-25
• Last updated: 2021-11-10

Locations

1 site across 1 country: Bulgaria