Manual of Procedures
CONFORM IDE Trial NCT05147792
Get The Entire Manual of Procedures
Download the established operational guidelines and best practices for the CONFORM Pivotal Trial with the CLAAS® Device.
20MAY2025
Access the Individual Files of The MOP Binder
MOP 2 - Study Contact List
V8.0 20MAY2025
MOP 3 - Site Personnel Training Requirements
V6.0 20MAY2025
MOP 4 - Conformal CCGs
V2.0 14Jan2025
MOP 5 – Study Schema Table
V 4.0 14JAN2025
MOP 6 - Randomization
V 2.0 14JAN2025
MOP 7 - Imaging Upload
V 4.0 14JAN2025
MOP 7A - Imaging Method Flowchart
V 1.0 14JAN2025
MOP 8 – Device Accountability WI
V 2.0 18OCT2023
MOP 8A – Return Devices
V 2.0 14JAN2025
MOP 8B – Device Accountability APP
V 2.0 18Oct2023
MOP 9 – Patient Implant Card
V 2.0 18OCT2023
MOP 10 - Protocol Deviations
V4.0 20MAY2025
MOP 11 - AE Adjudication Module
V 3.0 18OCT2023
MOP 12 – Pre-Procedure Review Process
V3.0 20MAY2025
MOP 12 – Appendix A Pre-Procedure Imaging Review Process Example
V5.0 05MAR2025
MOP 13 – Study Exit Flowchart
V 1.0 14JAN2025
MOP 14 – Submitting Planned-Scheduled Case
V1.0 20MAY2025