Interventistic Clinical Investigation on the Use of Medical Device in Subjects With Mild-moderate Osteoarticular Pain
NCT06422169 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2024-05-20
Summary
Evaluation of the performance and safety of ArToFILL in subjects with mild to moderate osteoarticular pain
Conditions
- Osteoarthritis, Knee
Interventions
- DEVICE
-
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 %.
Sponsors & Collaborators
-
PromoPharma spa
lead INDUSTRY
Principal Investigators
-
Michele Vecchio · Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco", P.O. "G. Rodolico"
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 84 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-08
- Primary Completion
- 2025-03-08
- Completion
- 2025-05-08
Countries
- Italy
Study Locations
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