Suprasorb® CNPendo Used for Negative Pressure Therapy in the Oesophagus and Rectum to Support Defect and Wound Healing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Esophagus Injury, Rectal Lesion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Primary outcome measures
- 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 frame: 3 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 7 centers
- Uniklinik Berlin Charite — Berlin
- Central Interdisciplinary Endoscopy, II. Medical Clinic Mannheim Medical University — Mannheim
- Clinic for general, visceral and transplant surgery at the University of Munich — Munich
- Uniklinik MRI — Munich
- Universitätsklinikum Münster (UKM) Klinik für Allgemein-, Viszeral- und Transplantationsch — Münster
- Klinikum Rheine, Mathias-Spital, Chirurgische Klinik I: Allgemein- und Viszeralchirurgie — Rheine
- Universitätsklinikum Tübingen, Innere Medizin I - Gastroenterologie, Gastrointestinale Onk — Tübingen
Identifiers
NCT: NCT05476263 · 2022-03