Could a simple gel stop bleeding after gut surgery?
NCT ID NCT05746884
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether applying a special gel to the wound site after removing growths from the duodenum (the first part of the small intestine) can lower the chance of serious bleeding. About 234 adults with large polyps will be randomly assigned to get the gel or standard care. The main goal is to see if fewer people in the gel group need a blood transfusion, hospital stay, or another procedure within 30 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hemostatic gel
- What this could lead to
- If it works, this gel could become a standard way to prevent dangerous bleeding after certain duodenal procedures, reducing the need for blood transfusions or repeat hospital visits.
- What could go wrong
- This is an early-stage trial with no phase designation, so results are uncertain. The gel may not reduce bleeding enough to be worth the extra cost or effort.
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.
- 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 234 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Sep 2028
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: Ampullary lesions * Single ampullary lesion ≥ 10mm * Resection via hot ampullectomy, injection/Endoscopic mucosal resection of adjacent lateral spreading component Duodenal Lesions * ≤ 2 lesions * Lesion ≥15mm * Resection via hot Endoscopic mucosal resection * Morphology: 0-Is, 0-IIa/b/c or combination, submucosal lesions Exclusion Criteria: * Inability to provide informed consent (including people with cognitive impairment); * Pregnant or breastfeeding women; * Allergy to PuraStat®; * "Cold" mucosal endoscopic resection; * Patient under guardianship or curatorship, or under a regime of deprivation of liberty; * Participating patient, or in a period of exclusion from another clinical trial; * Patient not benefiting from a social security scheme.
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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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Hôpital Privé Jean Mermoz
RECRUITINGLyon, France