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Could a dissolvable sponge replace medical glue for dangerous stomach vein bleeds?

NCT ID NCT07699354

Disease control Sponsor: Unity Health Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This trial tests whether an absorbable gelatin sponge works as well as cyanoacrylate glue for closing off enlarged stomach veins that can bleed. Both treatments are delivered via endoscopy with small coils. Participants are adults with a history of bleeding from these veins, and they will be followed for up to a year to see which approach more effectively stops blood flow in the vein.

What this could mean

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

Active substance
cyanoacrylate glue and absorbable gelatin sponge
What this could lead to
If the absorbable gelatin sponge works as well as the glue, it could offer a safer, equally effective option for treating bleeding stomach veins.
What could go wrong
This is a small, early-stage trial with only 64 participants, so results may not apply to everyone. The gelatin sponge might not close off the veins as effectively as the glue.

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

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

About 64 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

Inclusion Criteria: * Adults aged 18 years or older. * Gastric varices deemed suitable for EUS-guided endoscopic treatment. * History of suspected gastric variceal bleeding or active gastric variceal bleeding, with treatment intended for secondary prophylaxis. * Ability to provide informed consent directly or through a substitute decision maker. * Willingness and ability to undergo clinical follow-up, EUS assessment, and CT imaging. Exclusion Criteria: * Inability or unwillingness to provide informed consent directly or through a substitute decision maker. * No gastric varix present, or gastric varix too small or not amenable to combination therapy. * Contraindication to therapeutic EUS or endoscopy. * Contraindication to any study material used in the assigned treatment arm. * Contraindication to contrast-enhanced CT, if not clinically manageable. * Inability to complete planned follow-up. * Pregnancy. * Any clinical situation in which the treating endoscopist determines that randomization would be unsafe or inappropriate.

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Conditions

The condition(s) this trial relates to.

esophageal varices esophageal varices with bleeding portal hypertension

As listed by the trial registrant

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

Gastric varices Gastric varices bleeding Portal hypertension

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • St. Michael's Hospital - Unity Health Toronto

    Toronto, Ontario, M5B 1W8, Canada

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