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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12624001213538
Enrollment
1
Registered
2024-10-03
Start date
2025-01-24
Completion date
2028-12-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 prevent

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.

Sponsors

Orthocell Ltd.
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Healthy volunteers
No

Inclusion criteria

Retrospective cohort: 1. Underwent a peripheral nerve procedure using Remplir™. 2. No longer in clinical follow-up at the time of study enrolment. 3. Completed at least one outpatient follow-up visit post peripheral nerve procedure using Remplir™. Prospective cohort: 1. Underwent a peripheral nerve procedure using Remplir™. 2. Able to give informed consent in accordance with ICH GCP. 3. 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 criteria

1. Participated in the CG-006 clinical trial. 2. Specifically requested that their data was not to be used for research purposes (retrospective cohort only).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026