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Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device

NCT06087705 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 134

Last updated 2023-10-18

No results posted yet for this study

Summary

Patients who are to benefit from an injection of SYNOVIUM HCS as part of their care will be offered to participate in this study. Patients will need to sign a consent form to participate. Prior to SYNOVIUM HCS injection, patients will be asked a series of questions regarding their pain and disability. Data collected during follow-up visits can be compared to pre-injection data.

Conditions

  • Gonarthrosis

Interventions

DEVICE

Intra-articular injection of hyaluronic acid

The injection must necessarily be performed by a practitioner in compliance with the rules of asepsis. Procedure of use: * Before the injection, a rigorous prior disinfection of the area to be treated will be carried out. * Check the integrity of the sterility protector. * Take the syringe and remove the protective tip. * Hold the syringe body and insert a sterile intra-articular injection needle into the Luer-Lock system. * Gently turn the needle clockwise to secure the needle in the Luer-Lock system. * A visual check of the attachment of the needle will be carried out. * Remove the needle cap. * Inject slowly.

Sponsors & Collaborators

  • EVAMED

    collaborator OTHER

  • LCA Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Dominique BARON · CRRF en Milieu Marin de Trestel

Eligibility

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

Timeline & Regulatory

Start
2023-02-07
Primary Completion
2024-08-01
Completion
2024-08-01

Countries

  • France

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 NCT06087705 on ClinicalTrials.gov