RecruitingACTRN12624001213538

Post-Market Clinical Follow-up Study to Evaluate the Safety and Performance of Remplir™ Collagen Membrane in Peripheral Nerve Surgery

A retrospective and prospective observational study on the safety and performance of Remplir™ collagen membrane used in patients who underwent peripheral nerve surgery


Sponsor

Orthocell Ltd.

Enrollment

100 participants

Start Date

Jan 24, 2025

Study Type

Observational

Conditions

Summary

This is a retrospective and prospective observational study where data will be collected on participants who have received Remplir™ during a peripheral nerve surgical procedure in a real world setting. This study is aiming to provide data on the safety and performance of Remplir™ in a wide range of peripheral nerve surgical procedures and patients in the real world.


Eligibility

Sex: Both males and females

Inclusion Criteria8

  • Retrospective cohort:
  • Underwent a peripheral nerve procedure using Remplir™.
  • No longer in clinical follow-up at the time of study enrolment.
  • Completed at least one outpatient follow-up visit post peripheral nerve procedure using Remplir™.
  • Prospective cohort:
  • Underwent a peripheral nerve procedure using Remplir™.
  • Able to give informed consent in accordance with ICH GCP.
  • If <18 years of age at the time of study enrolment, able to give assent, and parent or legal guardian able to give informed consent in accordance with ICH GCP.

Exclusion Criteria2

  • Participated in the CG-006 clinical trial.
  • Specifically requested that their data was not to be used for research purposes (retrospective cohort only).

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Interventions

The exposure being observed is the use of Remplir collagen membrane in peripheral nerve surgery. The observation period will be dependent on the specific indication/intention of the surgical proced

The exposure being observed is the use of Remplir collagen membrane in peripheral nerve surgery. The observation period will be dependent on the specific indication/intention of the surgical procedure and associated length of time required to assess the success of the procedure: - Peripheral nerve protection (e.g. during treatment of compression syndromes/peripheral nerve tumour excision, or prophylactic use during other surgical procedures) - 6 months - Neuroma management (treatment or prevention) - 12 months - Reconstruction of peripheral nerve (including nerve transfer/free-functioning muscle transfer) - up to 24 months Participants still in normal clinical follow-up will be asked to provide consent for data collection, and to complete a global rating of change questionnaire. All patients who underwent (or undergo) a peripheral nerve procedure using Remplir with the site investigator(s) from the 21st November 2020 until closure of prospective recruitment will be screened for eligibility.


Locations(1)

WA, Australia

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