March 31, 2026

CONFORM Pivotal Trial 

CONFORM Investigators & Research Teams, 

We’ve released a new memo related to the CONFORM Pivotal Trial, the purpose of this memo is to clarify the intent of language, and outline steps that Conformal Medical intends to take to rectify the source of potential ambiguity around the topic of Pre-randomization Screen Failures.

In the recording below, Melissa Ricketts provides a brief overview of the memo:

• CONFORM Pivotal Trial Pre-randomization Screen Failures

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 March 27, 2026

The memo outlines the steps that sites should take for screen-on-table patients and pre-randomization screen failures ​

Important Notes​

Conformal Medical defines a subject as enrolled in the CONFORM Pivotal Study only after all of the following criteria are met:​

• First, the subject must have provided informed consent.​
• Second, all inclusion criteria must be satisfied, including the required imaging review.​
• Third, no exclusion criteria may be met.​
• Finally, the subject must have been randomized.​
• Subjects who do not meet eligibility and are not randomized are screen failures for the CONFORM Pivotal Study. These patients are not followed through the study.

Only when all these conditions are fulfilled is the subject considered enrolled in the CONFORM Pivotal Study and followed through the study per the protocol.

Duration of Follow-up

After a subject is randomized, subjects are followed per the schedule of the CONFORM study. The follow-up schedule is dependent on
whether the subject receives a device, and they are followed for either 18 months or for 5 years, per the protocol.

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Have suggestions or questions about this newsletter? 

Drop us a note at info@conformalmedical.com.