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Post Marketing Clinical Follow up Study to Evaluate the Performance and Safety of HYALEXO

NCT05229458 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 54

Last updated 2022-04-19

No results posted yet for this study

Summary

This trial is a post marketing clinical follow up study, aiming to evaluate the performance and safety of Hyalexo for pain relief in patients suffering from osteoarthritis or degenerative joint diseases.

The study will involve 54 subjects, who will be enrolled in 4 centers in France. The performance outcomes will be evaluated by the koos score, and VAS for pain, while the safety outcomes will be assessed by a safety checklist and by collecting all the adverse events (Adverse Event/Adverse Device Effect/Serious Adverse Event/Serious Adverse Device Effect/Unanticipated Serious Adverse Device Effect/Device Deficiencies) at all visits.

Conditions

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    collaborator OTHER

  • Yooyoung Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jerome Porterie, Dr · Cabinet de Cabinet de Rhumatologie

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2022-05-31
Completion
2022-12-31

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Entities

Diseases

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 NCT05229458 on ClinicalTrials.gov