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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05476263
Other study ID # 2022-03
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2024
Est. completion date September 2027

Study information

Verified date June 2024
Source Lohmann & Rauscher
Contact Daria Trofimenko, MD
Phone +49 (0)2631- 99 6385
Email Daria.Trofimenko@de.LRmed.com
Is FDA regulated No
Health authority
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 September 2027
Est. primary completion date September 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Central Interdisciplinary Endoscopy, II. Medical Clinic Mannheim Medical University Mannheim
Germany Clinic for general, visceral and transplant surgery at the University of Munich Munich

Sponsors (2)

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

Country where clinical trial is conducted

Germany, 

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
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