Finding studies
Finding studies
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Lead
BTL Industries Ltd.
This study will evaluate the clinical efficacy and performance of the BTL-899 device for changes in the musculoskeletal system, specifically of the upper and lower extremities. The study is a prospective, multi-center, open-label, single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the study device. At the baseline visit, the subject's weight will be recorded and subjects will fill in the Western Ontario and McMaster Universities questionnaire. The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899 will be applied over the designated area. Each therapy session will last 30 minutes. At the last therapy visit, the subject's weight will be recorded. In addition, subjects will receive Therapy Comfort, Subject Satisfaction Questionnaire and Western Ontario and McMaster Universities questionnaire to fill in. Safety measures will include documentation of adverse events (AE), which will be assessed after each procedure and at all of the follow-up visits. During the post-procedure visits (at 1-month and 3-month follow-up visits), the subject's satisfaction, Western Ontario and McMaster Universities questionnaire, and weight will be recorded. In addition, subjects will receive a Lifestyle Change Questionnaire to fill in.
Age
22–any
Sex
ALL
Healthy volunteers
Accepted
