Using Suprasorb® CNPendo for healing wounds in the esophagus and rectum
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
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 |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lohmann & Rauscher Industry-sponsored |
| Locations | 7 sites (Berlin and 6 other locations) |
| Trial ID | NCT05476263 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with acute transmural defects or injuries in the esophagus or rectum.
Not a fit: Patients with pre-existing coagulation disorders or those with defects involving the bronchial system will not benefit from this study.
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 performed: While this approach is based on a marketed device, similar studies have not been specified, indicating a potential for novel application.
Eligibility criteria
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 this trial is running
Berlin and 6 other locations
- 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)
- Uniklinik MRI — Munich, Germany (Not_yet_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)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.