---
title: CONFORM TRIAL PORTAL
---

[![CONFORM pivotal trial negative_blue RGB](https://info.conformalmedical.com/hs-fs/hubfs/CONFORM%20pivotal%20trial%20negative_blue%20RGB.png?width=200&height=78&name=CONFORM%20pivotal%20trial%20negative_blue%20RGB.png "CONFORM pivotal trial negative_blue RGB")](https://info.conformalmedical.com/conform-trial-portal?hsLang=en)

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# IFU & Protocol Documents

CONFORM IDE Trial NCT05147792

### CLAAS System IFU Rev. L

22July2025

[ Download Here

](https://info.conformalmedical.com/hubfs/60-00430_CLAAS%20System%20IFU_Rev%20L.pdf?hsLang=en)

### Protocol Rev. R

18Feb2026

[ Download Here

](https://info.conformalmedical.com/hubfs/(C-5)%20CONFORM%20Protocol%20Rev%20R%20Clean.pdf?hsLang=en)

### Protocol Synopsis Rev. R

18Feb2026

[ Download Here

](https://info.conformalmedical.com/hubfs/(C-13)%20CONFORM%20Protocol%20Rev%20R%20Synopsis.pdf?hsLang=en)

## Memos to File

### CONFORM Study -Use of Electronic Informed Consent (eConsent)

 05Dec2025

[ Download Here

](https://info.conformalmedical.com/hubfs/C-53_V1.0_CONFORM_eConsent-Memo-5%20Dec%202025.pdf?hsLang=en)

### CONFORM Study – Pre-Discharge TTE

 05Dec2025

[ Download Here

](https://info.conformalmedical.com/hubfs/C-52_V1.0_CONFORM_Post%20Procedure_Pre%20Discharge%20TTE-Memo-5%20Dev%202025.pdf?hsLang=en)

### CONFORM Study -Verbal Informed Consent

 05Dec2025

[ Download Here

](https://info.conformalmedical.com/hubfs/C-51_V1.0_CONFORM_Verbal%20Informed%20Consent-Memo-5%20Dec%202025.pdf?hsLang=en)

### CONFORM Study Pre-Randomization Screen Failures

 03March2026

[ Download Here

](https://info.conformalmedical.com/hubfs/C-48_CONFORM_trial_pre-randomization_screen_failures_V2.0.docx.pdf?hsLang=en)

![I/E Card ](https://info.conformalmedical.com/hs-fs/hubfs/Screenshot%202026-04-24%20at%2012.12.32%20PM.png?width=2000&name=Screenshot%202026-04-24%20at%2012.12.32%20PM.png)

## Inclusion / Exclusion Criteria Card Protocol Rev. R

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

24Apr2026

[ Download Print File Here

](https://info.conformalmedical.com/hubfs/Conformal%20Medical%20InclusionExclusion%20Card%20(60-00494%2c%20Rev%20E).pdf?hsLang=en)

## Redline Protocol and Summary of Changes

### Protocol Rev M to R redlines

[ Download Here

](https://info.conformalmedical.com/hubfs/(C-5)%20CONFORM%20Protocol%20Rev%20M%20to%20R%20redlines.pdf?hsLang=en)

### CONFORM Protocol Summary of Changes V13

[ Download Here

](https://info.conformalmedical.com/hubfs/(C-15)%20CONFORM%20Protocol%20Summary%20of%20Changes%20V13.pdf?hsLang=en)

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.