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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Esophagus Injury; Rectal Lesion

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

• Study Contact: Name: Daria Trofimenko, MD; Phone Number: +49 (0)2631- 99 6385; Email: Daria.Trofimenko@de.LRmed.com
• Study Contact Backup: Name: Martin Abel, PhD; Phone Number: +49 (0)2631- 99 6665; Email: Martin.Abel@de.LRmed.com

Study Locations

• Germany
  • Berlin, Germany
    • Recruiting
    • Uniklinik Berlin Charite
    • Contact: Konstantinos Kouladouros, MD
  • Mannheim, Germany
    • Recruiting
    • Central Interdisciplinary Endoscopy, II. Medical Clinic Mannheim Medical University
    • Contact: Sebastian Belle, MD, Prof
  • Munich, Germany
    • Recruiting
    • Clinic for general, visceral and transplant surgery at the University of Munich
    • Contact: Maria Burian, MD
  • Munich, Germany
    • Not yet recruiting
    • Uniklinik MRI
    • Contact: Jeannine Bachmann, MD
  • Münster, Germany, 48149
    • Recruiting
    • Universitätsklinikum Münster (UKM) Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
    • Contact: Jennifer Merten, MD
  • Rheine, Germany, 48431
    • Recruiting
    • Klinikum Rheine, Mathias-Spital, Chirurgische Klinik I: Allgemein- und Viszeralchirurgie
    • Contact: Mike Laukötter, Prof., MD
  • Tübingen, Germany, 72076
    • Recruiting
    • Universitätsklinikum Tübingen, Innere Medizin I - Gastroenterologie, Gastrointestinale Onkologie, Hepatologie, Infektiologie und Geriatrie
    • Contact: Ulrike Schlempf, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult female and male patients with acute defects, injuries and wounds in the oesophagus or rectum and an indication of treatment with Suprasorb® CNPendo system according to IFU and medical guidelines.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lohmann & Rauscher
• Collaborators: CRI-The Clinical Research Institute GmbH
• Investigators: Principal Investigator: Mike Laukötter, Prof., MD, Klinikum Rheine, Mathias-Spital

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2022-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No