Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06344481 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

The Hyalex First-in-Human Study

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Sep 2026 → May 31, 2027
See other at-risk trials from Hyalex Orthopaedics, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Sep 2026 to May 31, 2027 Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 2 entries
    • Enrollment closed, study ongoing
    • Study completion pushed from Sep 2026 to May 31, 2028
    • Eligibility criteria expanded, about 35 words
    • Site details revised at 2 of 2 sites
  2. Study sites revised (2)v6
  3. Phase: Phase 1 to Not applicablev5
  4. Study sites: 1 to 2v4
  5. Enrollment target: 20 to 15v3
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06344481
Lead Sponsor Hyalex Orthopaedics, Inc.
Conditions
(from sponsor)		 Cartilage Injury
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov