Clinical trial NCT05476263: Suprasorb® CNPendo Used for Negative Pressure Therapy in the Oesophagus and Rectum to Support Defect and Wound Healing
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophagus Injury
Rectal Lesion
Lead sponsor: Lohmann & Rauscher
Sponsor class: INDUSTRY
Collaborators: name: CRI-The Clinical Research Institute GmbH
First posted: 2022-07-27
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Central Interdisciplinary Endoscopy, II. Medical Clinic Mannheim Medical University
city: Munich
country: Germany
facility: Clinic for general, visceral and transplant surgery at the University of Munich
city: Münster
country: Germany
facility: Universitätsklinikum Münster (UKM) Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
city: Rheine
country: Germany
facility: Klinikum Rheine, Mathias-Spital, Chirurgische Klinik I: Allgemein- und Viszeralchirurgie
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen, Innere Medizin I - Gastroenterologie, Gastrointestinale Onkologie, Hepatologie, Infektiologie und Geriatrie
Study officials:
affiliation: Klinikum Rheine, Mathias-Spital
name: Mike Laukötter, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References: