CONFORM pivotal trial negative_blue RGB

Protocol & IFU Documents

CONFORM IDE Trial NCT05147792

Protocol Rev. K

17Dec2024
Download Here

Protocol Synopsis Rev. K

17Dec2024
Download Here

CLAAS System IFU Rev. L

12May2025

Coming Soon
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Inclusion / Exclusion Criteria Card Protocol Rev. K

For The CONFORM Pivotal Trial with The CLAAS® Device 

Download the Criteria Card Here

Archived IFU & Redline Documents

IFU Rev. J

Download Here

IFU Rev. E to J Redlines

Download Here

IFU Rev. J to K Redlines

Download Here

IFU Rev. K to L Redlines

Coming Soon

CAUTION: Investigational Device
The CLAAS System is limited by Federal (or United States) law to investigational use.