We’ve released three new memos related to the CONFORM Pivotal Trial, designed to help streamline enrollment and imaging processes at your site.
Please take a moment to watch the short video below from Sarah Gallagher, Conformal’s Executive Director of Clinical Affairs.
In the video, Sarah provides a brief overview of each memo:
Use of e-Consent
Pre-Discharge TTE
Verbal Informed Consent
Please reach out to your CONFORM Site Manager with questions. Thank you for your continued commitment to the CONFORM Trial and for your partnership in advancing patient care.
Effective as of December 5, 2025 CONFORM sites are permitted by Conformal to utilize eConsent process in accordance with the site institutional IRB regulatory requirements and SOPs.
Effective as of December 5, 2025 CONFORM sites are now able to obtain verbal consent from patients. Verbal consent applies ONLY to the collection of historical imaging data.
NOTE: Historical images will be sent to CONFORMAL via DICOM Drop. Please contact your Site Manager for access to the DICOM Drop account or CLICK HERE >
The CLAAS® AcuFORM™ System is limited by federal law (United States) to investigational use. Exclusively for clinical investigation outside the United States. Not approved for commercial use.
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