Actively Recruiting
Suprasorb® CNPendo Used for Negative Pressure Therapy in the Oesophagus and Rectum to Support Defect and Wound Healing
Led by Lohmann & Rauscher · Updated on 2025-09-12
110
Participants Needed
7
Research Sites
169 weeks
Total Duration
On this page
Sponsors
L
Lohmann & Rauscher
Lead Sponsor
C
CRI-The Clinical Research Institute GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Post-Market Clinical Follow-up (PMCF) study designed as non-interventional, observational, prospective, multicentre study in a routine clinical care setting using a marketed medical device in line with the corresponding Instruction for Use (IFU) in the intended patient population. Patients will be diagnosed and evaluated for eligibility in routine clinical care by expert centres in the indication of interest. They will be consecutively enrolled into the study provided that all inclusion and exclusion criteria are met and written consent is given to use their clinical routine data according to data privacy regulations. The study protocol does not define specific study procedures for patients enrolled. Therapies and procedures during the course of this study will be performed according to the decision of the treating physician based on current applicable medical guidelines and on local policy in clinical routine care.
CONDITIONS
Official Title
Suprasorb® CNPendo Used for Negative Pressure Therapy in the Oesophagus and Rectum to Support Defect and Wound Healing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Acute transmural defects, injuries, or wounds in the esophagus or rectum, including perforations and anastomotic insufficiencies
- Indication for treatment with the Suprasorb4 CNPendo system according to instructions for use and medical guidelines
- Signed informed consent for use of clinical data
You will not qualify if you...
- Pre-existing coagulation disorders with increased risk of bleeding
- Defects involving the bronchial system (bronchus, trachea, lungs)
- Any expected deviation from the instructions for use of Suprasorb4 CNPendo
- Known intolerance or allergy to any components of Suprasorb4 CNPendo
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Uniklinik Berlin Charite
Berlin, Germany
Actively Recruiting
2
Central Interdisciplinary Endoscopy, II. Medical Clinic Mannheim Medical University
Mannheim, Germany
Actively Recruiting
3
Clinic for general, visceral and transplant surgery at the University of Munich
Munich, Germany
Actively Recruiting
4
Uniklinik MRI
Munich, Germany
Not Yet Recruiting
5
Universitätsklinikum Münster (UKM) Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Münster, Germany, 48149
Actively Recruiting
6
Klinikum Rheine, Mathias-Spital, Chirurgische Klinik I: Allgemein- und Viszeralchirurgie
Rheine, Germany, 48431
Actively Recruiting
7
Universitätsklinikum Tübingen, Innere Medizin I - Gastroenterologie, Gastrointestinale Onkologie, Hepatologie, Infektiologie und Geriatrie
Tübingen, Germany, 72076
Actively Recruiting
Research Team
D
Daria Trofimenko, MD
CONTACT
M
Martin Abel, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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