CONFORM pivotal trial negative_blue RGB

IFU & Protocol Documents

CONFORM IDE Trial NCT05147792

CLAAS System IFU Rev. L

22July2025

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Protocol Rev. R

18Feb2026

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Protocol Synopsis Rev. R

18Feb2026
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Memos to File

CONFORM Study -Use of Electronic Informed Consent (eConsent)

05Dec2025
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CONFORM Study – Pre-Discharge TTE

05Dec2025
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CONFORM Study -Verbal Informed Consent

05Dec2025
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CONFORM Study Pre-Randomization Screen Failures

03March2026
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I/E Card

Inclusion / Exclusion Criteria Card Protocol Rev. R

For The CONFORM Pivotal Trial with The CLAAS® AcuFORM™ Device 

24Apr2026

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Redline Protocol and Summary of Changes

Protocol Rev M to R redlines

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CONFORM Protocol Summary of Changes V13

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CAUTION: Investigational Device
Limited by federal (or United States) law to investigational use. Outside the United States, the device is intended exclusively for clinical investigation. Not approved for commercial use.