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Advanced Cartilage Treatment With Injectable-hydrogel Validation of the Effect

NCT05186935 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-02-22

No results posted yet for this study

Summary

Multicentre, pivotal, non-randomized, prospective, open-label clinical investigation involving a new hydrogel, Hy2Care Injectable hydrogel, developed by Hy2Care B.V., Enschede, The Netherlands (hereafter referred to as "Hy2Care") to treat cartilage defects (\< 2 cm2) in the human knee. The product aims at functional repair of cartilage defects in the knee and regeneration of cartilage.

The objective of this clinical investigation is to demonstrate the clinical safety and performance of the Hy2Care Injectable hydrogel. Data from this clinical investigation will be used to support a CE marking application for the Hy2Care Injectable hydrogel.

Sites will be selected based on a documented site qualification procedure. The Principal Investigator at each site will be selected based on confirmed expertise in the orthopaedic field. Each site will have a designated Principal Investigator and one or more study coordinators collectively responsible for the study data collection, inclusive of screening, enrolment, evaluation and documentation, in accordance with the International Organization for Standardization (ISO) 14155 guidelines for Good Clinical Practice. Per site, one physician will be assigned as Principal Investigator. Other physicians will be referred to as 'sub-investigators'.

Conditions

  • Cartilage Damage

Interventions

DEVICE

Injectable Hydrogel treatment

The Injectable Hydrogel is a single use two-component injectable and bioresorbable hydrogel intended for treatment of cartilage defects in the knee, it is a medical device, exclusively for clinical investigations. The hydrogel is mixed intraoperatively and with an open knee procedure inserted into the cartilage defect, where it crosslinks and adheres to the cartilage with the use of a primer, allowing it to stay in place during movements of the knee. The hydrogel covers the defect to prevent formation of scar tissue and to allow cartilage to regenerate. The Injectable Hydrogel will be used in combination with general instruments typically used. The different components of the Injectable Hydrogel are arranged in two boxes: Components of the Injectable Hydrogel are grouped in plastic cover bags or packaged in vial boxes.This is a performance study, with a single arm, i.e Injectable Hydrogel. Recovery is monitored.

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • UMC Utrecht

    collaborator OTHER

  • Hy2Care BV

    lead INDUSTRY

Principal Investigators

  • Roel Custers, Dr · UMCU - Academic Hospital Utrecht

  • Barbara Kalkman, Dr · UMCU - Academica Hospital Utrecht

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • Netherlands

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 NCT05186935 on ClinicalTrials.gov