Trials / Recruiting
RecruitingNCT06344481
The Hyalex First-in-Human Study
A Prospective, Multicenter, Single-Arm, 2-Phase First-in-Human Feasibility Study of the HYALEX® Cartilage System
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Hyalex Orthopaedics, Inc. · Industry
- Sex
- All
- Age
- 21 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The Hyalex First-in-Human Study is a prospective, multicenter, open-label, single-arm, 2-phase, first-in-human study to evaluate the safety and technical performance of the HYALEX Knee Cartilage System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Surgical (Hyalex Cartilage Knee Implant) | Implantation of Hyalex Cartilage Knee Implant. |
Timeline
- Start date
- 2024-03-07
- Primary completion
- 2026-09-01
- Completion
- 2026-09-01
- First posted
- 2024-04-03
- Last updated
- 2025-06-29
Locations
2 sites across 1 country: Poland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06344481. Inclusion in this directory is not an endorsement.