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The Hyalex First-in-Human Study

NCT06344481 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-06-29

No results posted yet for this study

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

  • Cartilage Injury

Interventions

DEVICE

Surgical (Hyalex Cartilage Knee Implant)

Implantation of Hyalex Cartilage Knee Implant.

Sponsors & Collaborators

  • Hyalex Orthopaedics, Inc.

    lead INDUSTRY

Principal Investigators

  • Marcin Domzalski, MD · SPORTO, Łódź, Poland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-07
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Device
Yes

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06344481 on ClinicalTrials.gov