Suprasorb® CNPendo Used for Negative Pressure Therapy in the Oesophagus and Rectum to Support Defect and Wound Healing
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLohmann & Rauscher
About this trial
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
This trial does not accept healthy volunteersQualifiers
≥ 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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lohmann & Rauscher
Lead sponsor
CRI-The Clinical Research Institute GmbH
Collaborator
Source ClinicalTrials.gov