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

Last updated: September 25, 2024
Sponsor: Lohmann & Rauscher
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05476263
2022-03
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • ≥ 18 years of age

  • Acute transmural defects, injuries and wounds in oesophagus or rectum, includingperforations (iatrogenic or spontaneous) and anastomotic insufficiencies (Indexdefect)

  • Indication of treatment with Suprasorb® CNPendo system according to IFU and medicalguidelines

  • Signed informed consent for usage of data

Exclusion

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

Total Participants: 110
Study Start date:
June 03, 2024
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Central Interdisciplinary Endoscopy, II. Medical Clinic Mannheim Medical University

    Mannheim,
    Germany

    Active - Recruiting

  • Clinic for general, visceral and transplant surgery at the University of Munich

    Munich,
    Germany

    Active - Recruiting

  • Universitätsklinikum Münster (UKM) Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

    Münster, 48149
    Germany

    Active - Recruiting

  • Klinikum Rheine, Mathias-Spital, Chirurgische Klinik I: Allgemein- und Viszeralchirurgie

    Rheine, 48431
    Germany

    Active - Recruiting

  • Universitätsklinikum Tübingen, Innere Medizin I - Gastroenterologie, Gastrointestinale Onkologie, Hepatologie, Infektiologie und Geriatrie

    Tübingen, 72076
    Germany

    Active - Recruiting

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