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

Esophagus Injury Clinical Trial

— Velox  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05476263
• Other study ID #: 2022-03
• Status: Not yet recruiting
• Start date: January 1, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: July 2022
• Source: Lohmann & Rauscher
• Contact: Daria Trofimenko, MD
• Phone: +49 (0)2631- 99 6385
• Email: Daria.Trofimenko[@]de.LRmed.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: January 1, 2026
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophagus Injury
• Rectal Lesion

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lohmann & Rauscher	CRI-The Clinical Research Institute GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months