Clinical Trial

The Hyalex First-in-Human Study

Recruiting
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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-03-27; most recent amendment 2025-06-26.
Trial Details
NCT Number NCT06344481
Lead Sponsor Hyalex Orthopaedics, Inc.
Conditions Cartilage Injury
Enrollment 15 participants
Start Date 2024-03-07
Primary Completion 2026-09 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2025-06-29