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AI takes on aortic aneurysm detection: could it beat human error?

NCT ID NCT07438327

Diagnosis Sponsor: Aiatella Oy Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an artificial intelligence software called Aorta AIM that automatically measures the size of the aorta from CT scans. The aorta can enlarge over time, leading to serious health problems, and accurate measurement is key for monitoring. Researchers will compare the AI's measurements to those made by expert radiologists using existing CT scans from 250 adults in Brazil and the U.S. No extra scans or procedures are needed, so there are no risks to participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aorta AIM software (artificial intelligence diagnostic tool)
What this could lead to
If successful, this AI could help doctors detect and monitor aortic aneurysms more quickly and consistently, potentially leading to earlier treatment decisions.
What could go wrong
This is an early-stage study comparing AI to human experts, not a treatment trial. The AI may not work as well in all patients or hospital settings, and it won't directly improve health outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients (≥22 years of age) who underwent CT imaging of the aorta (whole, thoracic, or abdominal) as part of routine clinical care between January 1, 2016 and August 31, 2025. CT scans must include imaging of the aorta with or without contrast enhancement and have slice thickness ≤3mm. Patients with metal implants within 5cm of the aorta, prior aortic surgery, severe motion artifacts, congenital aortic anomalies, or post-traumatic aortic repairs are excluded. Patients who opted out of having their data used for medical research are also excluded. Retrospectively collected, de-identified CT imaging data from approximately 250 cases across multiple international sites in the United States and Latin America will be analyzed.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* Adults ≥22 years at time of imaging * Studies performed 1 Jan 2016 - 31 August 2025 * CT imaging of the whole, thoracic, or abdominal aorta, with or without contrast enhancement, acquired with any gating protocol (including non-gated) * Slice thickness ≤ 3mm * CT imaging in which truncation creates discontinuity within a targeted aortic region, preventing reliable diameter measurement (e.g., cardiac-focused CT acquisitions where an incomplete or absent aortic arch creates discontinuity between the aortic root and the descending thoracic aorta) o Partial aortic coverage is not grounds for exclusion. Where truncation affects individual regions, only those specific regions will be excluded from analysis; remaining fully captured regions will be retained for measurement. * Metal implants \<5cm from aorta (e.g. thoracic stent) * Prior aortic surgery * Severe motion artifacts (e.g. \>3mm vessel blurring) * Congenital aortic anomalies (e.g. coarctation, vascular rings) * Post-traumatic aortic repairs * The patient opted out of having their data used for medical research before the date of cross-referencing by the site team

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Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm aortic aneurysm Aortic Aneurysm, Thoracoabdominal Aortic Dissection familial thoracic aortic aneurysm and aortic dissection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic aneurysm Aortic aneurysm and dissection Aortic aneurysm, abdominal Aortic aneurysm, thoracoabdominal

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Israelita Albert Einstein

    NOT_YET_RECRUITING

    São Paulo, São Paulo, 05652-900, Brazil

  • Innovation Health Services

    RECRUITING

    Norfolk, Virginia, 23510, United States

    Contact Email: •••••@•••••

  • University of North Carolina at Chapel Hill

    NOT_YET_RECRUITING

    Chapel Hill, North Carolina, 27599, United States

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