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Evaluation of Safety and Efficacy of the BTL-785F Device for Improving the Structure of Facial Muscles
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.
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.
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Yael Halaas, M.D., FACS
New York, New York, United States
Start Date
June 27, 2022
Primary Completion Date
December 10, 2022
Completion Date
May 23, 2023
Last Updated
July 18, 2024
10
ACTUAL participants
BTL-785-7
DEVICE
Lead Sponsor
BTL Industries Ltd.
NCT07187297
NCT07255261
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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