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

Recruiting

• Conditions: Esophagus Injury; Rectal Lesion

• Registration Number: NCT05476263
• Lead Sponsor: Lohmann & Rauscher

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-07-26
• Study First Posted: 2022-07-27
• Study Start: 2024-06-03
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-25
• Last Update Posted: 2024-09-27
• Primary Completion: 2026-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).	3 months	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.

Trial Locations

Locations (5)

Universitätsklinikum Münster (UKM) Klinik für Allgemein-, Viszeral- und Transplantationschirurgie; 🇩🇪 Münster, Germany

Klinikum Rheine, Mathias-Spital, Chirurgische Klinik I: Allgemein- und Viszeralchirurgie; 🇩🇪 Rheine, Germany

Universitätsklinikum Tübingen, Innere Medizin I - Gastroenterologie, Gastrointestinale Onkologie, Hepatologie, Infektiologie und Geriatrie; 🇩🇪 Tübingen, Germany

Central Interdisciplinary Endoscopy, II. Medical Clinic Mannheim Medical University; 🇩🇪 Mannheim, Germany

Clinic for general, visceral and transplant surgery at the University of Munich; 🇩🇪 Munich, Germany