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| Name | Class |
|---|---|
| CRI-The Clinical Research Institute GmbH | INDUSTRY |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Time period in days from index use of Suprasorb® CNPendo to release for oral food intake (in upper GI tract use) or release for stoma relocation (in lower GI tract use). | Time period in days from index use of Suprasorb® CNPendo to release for oral food intake (in upper GI tract use) or release for stoma relocation (in lower GI tract use). In case of lower GI tract use and no stoma present, time period to release for oral food intake is the relevant endpoint. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daria Trofimenko, MD | Contact | +49 (0)2631- 99 6385 | Daria.Trofimenko@de.LRmed.com | |
| Martin Abel, PhD | Contact | +49 (0)2631- 99 6665 | Martin.Abel@de.LRmed.com |
| Name | Affiliation | Role |
|---|---|---|
| Mike Laukötter, Prof., MD | Klinikum Rheine, Mathias-Spital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniklinik Berlin Charite | Recruiting | Berlin | Germany |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 7, 2023 | Sep 25, 2024 | Prot_000.pdf |
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| Central Interdisciplinary Endoscopy, II. Medical Clinic Mannheim Medical University | Recruiting | Mannheim | Germany |
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| Clinic for general, visceral and transplant surgery at the University of Munich | Recruiting | Munich | Germany |
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| Uniklinik MRI | Not yet recruiting | Munich | Germany |
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| Universitätsklinikum Münster (UKM) Klinik für Allgemein-, Viszeral- und Transplantationschirurgie | Recruiting | Münster | 48149 | Germany |
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| Klinikum Rheine, Mathias-Spital, Chirurgische Klinik I: Allgemein- und Viszeralchirurgie | Recruiting | Rheine | 48431 | Germany |
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| Universitätsklinikum Tübingen, Innere Medizin I - Gastroenterologie, Gastrointestinale Onkologie, Hepatologie, Infektiologie und Geriatrie | Recruiting | Tübingen | 72076 | Germany |
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