An observational study in Esophagus Injury and Rectal Lesion, sponsored by Lohmann & Rauscher. Recruiting at 7 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Lohmann & Rauscher · Observational
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.
Lohmann & Rauscher is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 months
Plan to share: No
Started Jun 2024 (actual). Primary completion is estimated for Sep 2026, 27 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lohmann & Rauscher