Using Suprasorb® CNPendo for healing wounds in the esophagus and rectum
Official title: Non-interventional, Observational, Prospective, Multicentre Study in a Routine Clinical Care Setting Using a Marketed Medical Device in Line With the Corresponding IFU in the Intended Patient Population
Run by Lohmann & Rauscher · NCT05476263 · Data updated 2026-11-12
This study is testing if the Suprasorb® CNPendo device can help heal wounds in the esophagus and rectum for patients with acute injuries.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Lohmann & Rauscher Industry-sponsored |
| Locations | 7 sites (Berlin and 6 other locations) |
| Status | Recruiting |
| Started | June 3, 2024 |
| Main results expected | September 2026 |
| Study ends | September 2027 |
| Registry record updated | September 12, 2025 |
| Trial ID | NCT05476263 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with acute transmural defects or injuries in the esophagus or rectum.
✕Probably not a fit
Patients with pre-existing coagulation disorders or those with defects involving the bronchial system will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the effectiveness of the Suprasorb® CNPendo device in promoting wound healing for patients with acute injuries or defects in the esophagus and rectum. Conducted in a routine clinical care setting, patients will be enrolled based on their eligibility as determined by expert centers. The study will collect clinical data without imposing specific procedures, allowing treating physicians to follow standard medical guidelines. Written consent will be obtained from participants to use their clinical data in accordance with privacy regulations.
Why it matters
Potential benefit: If successful, this approach could enhance healing outcomes for patients with serious injuries in the esophagus and rectum.
How similar studies have gone: While this approach is based on a marketed device, similar studies have not been specified, indicating a potential for novel application.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Uniklinik Berlin Charite
Berlin, Germany Recruiting -
Central Interdisciplinary Endoscopy, II. Medical Clinic Mannheim Medical University
Mannheim, Germany Recruiting -
Clinic for general, visceral and transplant surgery at the University of Munich
Munich, Germany Recruiting -
Universitätsklinikum Münster (UKM) Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Münster, Germany Recruiting -
Klinikum Rheine, Mathias-Spital, Chirurgische Klinik I: Allgemein- und Viszeralchirurgie
Rheine, Germany Recruiting -
Universitätsklinikum Tübingen, Innere Medizin I - Gastroenterologie, Gastrointestinale Onkologie, Hepatologie, Infektiologie und Geriatrie
Tübingen, Germany Recruiting
Show 1 more location
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Uniklinik MRI
Munich, Germany Not yet recruiting
Study contacts
- Principal investigator: Mike Laukötter, Prof., MD — Klinikum Rheine, Mathias-Spital
- Study coordinator: Daria Trofimenko, MD
- Email: Daria.Trofimenko@de.LRmed.com
- Phone: +49 (0)2631- 99 6385
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.