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

Plain Language Summary

Simplified for easier understanding

Remplir is a collagen membrane — a thin, biocompatible sheet made from a natural protein — that is used during peripheral nerve surgery to wrap around and protect repaired nerves. It is designed to reduce scar tissue formation around the nerve after surgery, which can otherwise limit recovery. This post-market study is collecting real-world data on how Remplir performs across a wide range of peripheral nerve procedures and patient types. Both past patients (retrospective) who have already had Remplir used in their surgery and new patients (prospective) who will have it used will be included. Data on nerve function recovery, surgical outcomes, and any complications will be collected and analysed. You may be eligible if you have undergone (or are about to undergo) a peripheral nerve surgical procedure in which Remplir was or will be used. There are no specific age restrictions. People who participated in the original CG-006 clinical trial for Remplir, or those who have specifically stated they do not want their data used for research, are not eligible. This study will help build the evidence base for this medical device and guide its use in future nerve surgery.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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ACTRN12624001213538