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

L

Lohmann & Rauscher (L&R)

Status

Not yet enrolling

Conditions

Esophagus Injury
Rectal Lesion

Study type

Observational

Funder types

Industry

Identifiers

NCT05476263
2022-03

Details and patient eligibility

About

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.

Enrollment

110 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

I1. Acute transmural defects, injuries and wounds in oesophagus or rectum, including perforations (iatrogenic or spontaneous) and anastomotic insufficiencies I2. Indication of treatment with Suprasorb® CNPendo system according to IFU and medical guidelines I3. Signed informed consent for usage of data

Exclusion criteria

E1. Pre-existing coagulation disorders with increased risk of bleeding E2. Defects involving the bronchial system (bronchus/trachea/pulmo) E3. Direct contact of foam drainage with exposed intestinal serosa E4. Direct contact of foam drainage with oesophageal varices E5. Direct contact of the foam drainage with large blood vessels E6. Irreversible ischemia in the treatment area E7. Known intolerance or allergy to one or more components of Suprasorb® CNPendo

Trial contacts and locations

0

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Central trial contact

Daria Trofimenko, MD; Martin Abel, PhD

Data sourced from clinicaltrials.gov

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