MedTrace Logo

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

NCT05476263 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2025-09-12

No results posted yet for this study

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

Sponsors & Collaborators

  • CRI-The Clinical Research Institute GmbH

    collaborator INDUSTRY

  • Lohmann & Rauscher

    lead INDUSTRY

Principal Investigators

  • Mike Laukötter, Prof., MD · Klinikum Rheine, Mathias-Spital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-03
Primary Completion
2026-09-30
Completion
2027-09-30

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05476263 on ClinicalTrials.gov