RecruitingNCT05476263

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

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


Sponsor

Lohmann & Rauscher

Enrollment

110 participants

Start Date

Jun 3, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • ≥ 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 Criteria4

  • 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

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Locations(7)

Uniklinik Berlin Charite

Berlin, 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

Uniklinik MRI

Munich, Germany

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

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NCT05476263


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