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

NCT05476263 | Recruiting DMC

• 1 other identifier: 2022-03
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 7

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.

Conditions

Esophagus Injury; Rectal Lesion

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lohmann & Rauscher: lead
• CRI-The Clinical Research Institute GmbH: collaborator

Study Sites (7)

Uniklinik Berlin Charite

Berlin, Germany

RECRUITING

Central Interdisciplinary Endoscopy, II. Medical Clinic Mannheim Medical University

Mannheim, Germany

RECRUITING

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

Munich, Germany

RECRUITING

Uniklinik MRI

Munich, Germany

NOT YET RECRUITING

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

Münster, 48149, Germany

RECRUITING

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

Rheine, 48431, Germany

RECRUITING

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

Tübingen, 72076, Germany

RECRUITING

Study Officials

• Mike Laukötter, Prof., MD

  Klinikum Rheine, Mathias-Spital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daria Trofimenko, MD

CONTACT

+49 (0)2631- 99 6385; Daria.Trofimenko@de.LRmed.com

Martin Abel, PhD

CONTACT

+49 (0)2631- 99 6665; Martin.Abel@de.LRmed.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 27, 2022
• Study Start: June 3, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 12, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7)