AI second pair of eyes could speed up finding hidden bleeding
NCT ID NCT07824739
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are testing an AI software tool called DSA-VDet v1.0 that highlights suspected bleeding on angiography images in real time. The trial enrolls adults with suspected acute bleeding in various body regions who need a digital subtraction angiography (DSA) procedure. Doctors will use the software as a second reader while they interpret the images, and the study measures whether this assistance shortens the time to reach a correct diagnosis compared with standard interpretation alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an AI software tool called DSA-VDet v1.0 that highlights suspected bleeding on angiography images in real time
- What this could lead to
- If it works, the software could help doctors find bleeding sites faster during angiography, which may reduce repeat scans and radiation exposure.
- What could go wrong
- The trial may show the software does not speed up diagnosis or improve accuracy compared with doctors reading images alone. It is a diagnostic aid, not a treatment, and any benefit depends on how well it performs across different patients and bleeding locations.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 1,324 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide 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.
Inclusion Criteria: * age 18 years or older; * suspected acute active bleeding in an intracranial, solid-organ, pelvic, gastrointestinal, respiratory, great-vessel, or other relevant anatomical region requiring DSA-guided interventional diagnosis or treatment; * clinical suitability for the planned DSA procedure; * written informed consent from the patient or legally authorized representative before randomization whenever feasible, or eligibility for an ethics-approved deferred-consent pathway at an activated site when prior consent is impossible and treatment cannot be delayed. Exclusion Criteria: * a history of severe allergic reaction to iodinated contrast medium or related medications that precludes the planned procedure; * severe coagulopathy or a platelet count below 50x10\^9/L when interventional treatment is considered clinically inappropriate; * severe cardiac or pulmonary insufficiency that makes the planned procedure unsafe; * pregnancy or breastfeeding; * severe renal insufficiency or another condition that may substantially increase interventional risk; * inability to complete angiography safely according to the required workflow despite clinically appropriate support; * any other circumstance that, in the investigator's judgment, makes participation unsuitable. Impaired decision-making capacity alone will not be an exclusion if consent can be obtained from a legally authorized representative or through the ethics-approved deferred-consent pathway.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Zhongda hospital
Nanjing, Jiangsu, 213003, China
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