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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05476263

Acronym

Velox

Enrollment

110

Registered

2022-07-27

Start date

2024-06-03

Completion date

2027-09-30

Last updated

2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagus Injury, Rectal Lesion

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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).	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.

Countries

Germany

Contacts

Primary ContactDaria Trofimenko, MD

Daria.Trofimenko@de.LRmed.com+49 (0)2631- 99 6385

Backup ContactMartin Abel, PhD

Martin.Abel@de.LRmed.com+49 (0)2631- 99 6665

Outcome results