Suprasorb® CNPendo Used for Negative Pressure Therapy in the Oesophagus and Rectum to Support Defect and Wound Healing

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Esophagus Injury, Rectal Lesion

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: I1. Acute transmural defects, injuries and wounds in oesophagus or rectum, including perforations (iatrogenic or spontaneous) and anastomotic insufficiencies I2. Indication of treatment with Suprasorb® CNPendo system according to IFU and medical guidelines I3. Signed informed consent for usage of data Exclusion Criteria: E1. Pre-existing coagulation disorders with increased risk of bleeding E2. Defects involving the bronchial system (bronchus/trachea/pulmo) E3. Direct contact of foam drainage with exposed intestinal serosa E4. Direct contact of foam drainage with oesophageal varices E5. Direct contact of the foam drainage with large blood vessels E6. Irreversible ischemia in the treatment area E7. Known intolerance or allergy to one or more components of Suprasorb® CNPendo

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |