REDUCE Registry - Rev C.EU, February 14th 2025
Research type
Research Database
IRAS ID
355873
Contact name
Laura O'Brien
Contact email
Research summary
The Cryoanalgesia Registry for Pain Management in Post-cardiothoracic Surgery Via Cryoablation of the intercostal nerves (REDUCE) Registry
REC name
East Midlands - Derby Research Ethics Committee
REC reference
25/EM/0119
Date of REC Opinion
24 Jun 2025
REC opinion
Further Information Favourable Opinion
Data collection arrangements
To measure the efficacy of the cryo nerve block procedure to generate cryoanalgesia as post operative pain management, the study will collect pain scores to assess the effect of the Cryoanalgesia and data on adverse events, to assess the safety of the procedure.
The Sponsor and/or its affiliates, will maintain documentation of the systems and procedures used in data collection for the duration of the registry. Clinical Research Forms (CRF) data collection will be performed through a secure web portal and only authorized personnel will access the Electronic Data Capture (EDC) system, using a unique username and password to enter, review or correct data. Passwords and electronic signatures will be strictly confidential.
The data will be subjected to consistency and validation checks within the EDC system and supplemental review by the Sponsor.
For the duration of the registry, the Principal Investigator will maintain complete and accurate documentation including, but not limited to, medical records, CRFs, and signed ICFs, correspondence with the IRB and Sponsor, adverse event reports, and information regarding subject discontinuation. The Principal Investigator shall assure the accuracy, attribution, completeness, legibility and timeliness of the data reported to the Sponsor on the CRFs and in all required reports.Research programme
This database will support research on an alternative pain management modality for patients going through cardiothoracic surgery.
Research database title
The Cryoanalgesia Registry for Pain Management in Post-cardiothoracic Surgery Via Cryoablation of the intercostal nerves (REDUCE) Registry
Establishment organisation
AtriCure BV
Establishment organisation address
De Entree II,
De Entree 260,
Amsterdam, The Netherlands
1101 EE