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

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.

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Key information

Conditions

Esophagus Injury Rectal Lesion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uniklinik Berlin Charite, Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 frame: 3 months

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daria Trofimenko, MD

CONTACT

[email protected]

+49 (0)2631- 99 6385

Martin Abel, PhD

CONTACT

[email protected]

+49 (0)2631- 99 6665

Sponsors and collaborators

Lead sponsor

Lohmann & Rauscher

Industry

Collaborators

CRI-The Clinical Research Institute GmbH

Registry information

Official study 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

Acronym: Velox

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: Jul 27, 2022
Registry last updated: Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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