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
Orthocell Ltd.
100 participants
Jan 24, 2025
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
Plain Language Summary
Simplified for easier understanding
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.
Interested in this trial?
Get notified about updates and connect with the research team.
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 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)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12624001213538