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Interventistic Clinical Investigation on the Use of Medical Device in Subjects With Mild-moderate Osteoarticular Pain
Sponsor: PromoPharma spa
Summary
Evaluation of the performance and safety of ArToFILL in subjects with mild to moderate osteoarticular pain
Official title: Interventistic Monocentric Pre-market Clinical Investigation on the Use of Medical Device "ArToFILL" in Subjects With Mild-moderate Osteoarticular Pain
Key Details
Gender
All
Age Range
18 Years - 84 Years
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2024-05-08
Completion Date
2025-05-08
Last Updated
2024-05-20
Healthy Volunteers
No
Conditions
Interventions
ArToFILL
ArToFILL is an injectable medical device (class III) intended for use as a temporary filler in joints. It is a sterile, non-pyrogenic, colorless and transparent hyaluronic acid gel of non-animal origin. ArToFILL is a hydrogel consisting of a mixture of two different molecular weights of hyaluronic acid, for a total HA concentration of 2.7 %.
Locations (1)
U.O. Recupero e riabilitazione funzionale P.O. "G.Rodolico", Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"
Catania, Italy