Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06368700 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

The HYALEX Pivotal Study

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 1 of 2 entries
    • Study sites: 4 to 5
    • Eligibility criteria expanded, about 24 words
  2. Enrollment target: 20 to 85v4 Show 6 more changesShow less
    • Primary completion date: Oct 2025 to Dec 2027
    • Primary endpoints revised (2)
    • Study completion date: Oct 2026 to Dec 2028
    • Eligibility criteria shortened, about 89 words
    • Site contacts updated at 4 of 4 sites
    • Study title shortened, about 2 words
  3. Phase: Phase 1 to Not applicable
    • Site contacts updated at 4 of 4 sites
    • Eligibility criteria shortened, about 4 words
    v3
  4. Study sites: 2 to 4v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A multicenter, open-label, single-arm, pivotal study to evaluate the safety and effectiveness of the HYALEX Freestyle Resurfacing System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment, will be enrolled in the study and undergo implantation of the HYALEX Freestyle Resurfacing Implant.
Trial Details
NCT Number NCT06368700
Lead Sponsor Hyalex Orthopaedics, Inc.
Conditions
(from sponsor)		 Damaged Chondral or Osteochondral Area
Enrollment 85 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov