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Patient's own blood turned into surgical glue to stop deadly leaks

NCT ID NCT05713955

NEW Prevention Sponsor: University Hospital, Ghent Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

After surgery to remove esophageal cancer, surgeons reconnect the food pipe to the stomach. This new join can leak, causing serious problems or death. Researchers are testing a glue made from the patient's own blood plasma, called BioMatrix OBSiDiAN, applied during the operation. The trial enrolls 90 adults with esophageal cancer to see if the glue is safe and reduces leaks.

What this could mean

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

Active substance
a surgical glue made from the patient's own blood plasma, called BioMatrix OBSiDiAN
What this could lead to
If it works, surgeons could use a patient's own blood to seal the join between the food pipe and stomach, cutting a leak rate that can reach 40 percent.
What could go wrong
The trial is small and early stage, so the glue may not lower leak rates or may fail to work in a larger group. Applying the glue adds time and complexity to an already invasive operation.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

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

Started

Jun 2025

Expected to finish

Jan 2027

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 to 75 years

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.

1. Inclusion criteria Preoperatively * Subjects ≥ 18 years and ≤ 75 years who are willing to participate and provide written informed consent prior to any study-related procedures. * Subjects with esophageal carcinoma (distal until Siewert II) scheduled for elective minimally invasive Ivor Lewis esophagectomy (cT1-4a,N0-3,M0). Intra-operatively \- Intrathoracic circular stapled esophagogastric anastomosis 2. Exclusion criteria preoperatively * Female patients who are pregnant or nursing * Participation in another study involving investigational drugs or devices. * Use of Avastin within 30 days prior to surgery * ASA IV (patient with severe systemic disease that is a constant threat to life) * Patients with other malignancies * Patients with previous esophageal or gastric surgery * Known hypersensitivity to batroxobin and tranexamic acid. * HB level \< 8 g/dL * Patients on medicine containing acetylsalicylic acid not able to stop using the medicine for medical reasons minimum 3 days before taking the blood sampling. * Patients on clopidogrel not able to stop clopidogrel for medical reasons 7 days before blood sampling * Patients on other platelet aggregation inhibitor therapies not able to stop using the platelet aggregation inhibitor therapies for 3 days before taking the blood sample. Intra-operatively * Intra-operative findings that may preclude conduct of the study procedures, such as pleural metastasis, tumor invasion in other organs, … * Anastomosis preformed differently than the standard of care * Excessive bleeding (\>500 ml) prior to anastomosis

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Conditions

The condition(s) this trial relates to.

Anastomotic Leak carcinoma of esophagus

As listed by the trial registrant

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

Anastomotic leak esophagus

How to take part

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

  1. The places running it

    2 sites. 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

  • University Hospital Ghent

    NOT_YET_RECRUITING

    Ghent, East-Flanders, 9000, Belgium

  • University Hospital Ghent

    RECRUITING

    Ghent, East-Flanders, 9000, Belgium

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