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New study observes how a wound device helps heal gut injuries

NCT ID NCT05476263

Knowledge-focused Sponsor: Lohmann & Rauscher 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study follows 110 adults with acute tears or holes in the esophagus or rectum who are treated with a medical device called Suprasorb CNPendo. Researchers will track how long it takes for patients to start eating again or have their stoma closed. The goal is to see how well the device works in everyday hospital care.

What this could mean

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

Active substance
Suprasorb® CNPendo (a medical device for wound healing)
What this could lead to
If successful, this study could confirm that Suprasorb CNPendo helps people with esophagus or rectal injuries recover faster, allowing them to eat or have stoma closure sooner.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other treatments. The device is already on the market, so no major new breakthrough is expected.

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 110 people

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

Started

Jun 2024

Expected to finish

Sep 2027

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 female and male patients with acute defects, injuries and wounds in the oesophagus or rectum and an indication of treatment with Suprasorb® CNPendo system according to IFU and medical guidelines.

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: * ≥ 18 years of age * Acute transmural defects, injuries and wounds in oesophagus or rectum, including perforations (iatrogenic or spontaneous) and anastomotic insufficiencies (Index defect) * Indication of treatment with Suprasorb® CNPendo system according to IFU and medical guidelines * Signed informed consent for usage of data Exclusion Criteria: * Pre-existing coagulation disorders with increased risk of bleeding * Defects involving the bronchial system (bronchus/trachea/pulmo) * Any foreseeable deviation from IFU of Suprasorb® CNP endo * Known intolerance or allergy to one or more components of Suprasorb® CNPendo

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Conditions

The condition(s) this trial relates to.

Boerhaave syndrome injury

As listed by the trial registrant

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

Esophagus injury Rectal lesion

How to take part

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

  1. The places running it

    7 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

  • Central Interdisciplinary Endoscopy, II. Medical Clinic Mannheim Medical University

    RECRUITING

    Mannheim, Germany

  • Clinic for general, visceral and transplant surgery at the University of Munich

    RECRUITING

    Munich, Germany

  • Klinikum Rheine, Mathias-Spital, Chirurgische Klinik I: Allgemein- und Viszeralchirurgie

    RECRUITING

    Rheine, 48431, Germany

  • Uniklinik Berlin Charite

    RECRUITING

    Berlin, Germany

  • Uniklinik MRI

    NOT_YET_RECRUITING

    Munich, Germany

  • Universitätsklinikum Münster (UKM) Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

    RECRUITING

    Münster, 48149, Germany

  • Universitätsklinikum Tübingen, Innere Medizin I - Gastroenterologie, Gastrointestinale Onkologie, Hepatologie, Infektiologie und Geriatrie

    RECRUITING

    Tübingen, 72076, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.