NCT06422169

Interventistic Clinical Investigation on the Use of Medical Device in Subjects With Mild-moderate Osteoarticular Pain

Interventistic Monocentric Pre-market Clinical Investigation on the Use of Medical Device "ArToFILL" in Subjects With Mild-moderate Osteoarticular Pain

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: PromoPharma spa · Industry
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the performance and safety of ArToFILL in subjects with mild to moderate osteoarticular pain

Detailed description

Monocenter, prospective, open label, interventional clinical investigation evaluating the performance and safety of 3 intra-articular injections of ArToFILL for the treatment of mild-moderate osteoarticular pain.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
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 %.

Timeline

• Start date: 2024-05-08
• Primary completion: 2025-03-08
• Completion: 2025-05-08
• First posted: 2024-05-20
• Last updated: 2024-05-20

Locations

1 site across 1 country: Italy