NCT07516457

Hydrogel Assessment for Local Treatment of Osteoarthritis

A Prospective, Multi-Center, Open-Label Study to Evaluate the Safety and Tolerability of Hydrogel OA 2% in Patients With Knee Osteoarthritis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Allegro NV/SA · Industry
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study aims to evaluate the safety and tolerability of one intra-articular injection of Hydrogel OA 2% for the symptomatic treatment of osteoarthritis of the knee.

Detailed description

The primary objective of this investigation is to assess the safety and tolerability of Hydrogel OA 2% in subjects with symptomatic KOA up to 13 weeks after injection of the device. The secondary objective of this investigation is to assess the safety and tolerability of Hydrogel OA 2% in subjects with symptomatic KOA up to 12 months after injection of the device. The exploratory objective of this investigation is to assess the clinical efficacy of Hydrogel OA 2% in subjects with symptomatic KOA.

Conditions

• Osteo Arthritis of the Knee

Interventions

Type	Name	Description
DEVICE	Injection of Hydrogel OA 2%	Single injection

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-12-31
• Completion: 2027-09-30
• First posted: 2026-04-08
• Last updated: 2026-04-13

Locations

3 sites across 1 country: Belgium