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NCT04734912 Clinical Trial

Evaluation of Transnasal Endoscopy During COVID-19 Pandemic

Endoscopy Clinical Trial

Official title:
Evaluation of Transnasal Endoscopy During COVID-19 Pandemic

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04734912
Other study ID # ETNE v1.0
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 13, 2021
Est. completion date December 31, 2021

Study information
Verified date January 2021
Source Johannes Gutenberg University Mainz
Contact Helmut Neumann, M.D. PhD
Phone +49 (0) 6131
Email helmut.neumann@unimedizin-mainz.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients who received the indication for endoscopic diagnostics using gastroscopy in transnasal technique will be included into the study. The examination is carried out in standard technique and is not influenced by the study. Following the examination, patient data is collected pseudonymously and a questionnaire is submitted to the patient.

Description:

COVID-19 is transmitted, among other things, by a droplet infection. Conventional gastroscopy through the patient's mouth is therefore considered a high-risk examination for the medical and nursing staff. Alternatively, gastroscopy can also be performed through the patient's nose. An advantage here is that the aerosol formation is naturally significantly reduced and the patient usually does not need sedation, since in transnasal endoscopy no stranglehold occurs. Transnasal endoscopy therefore appears to us, especially during the COVID-19 pandemic, as a safe alternative to conventional gastroscopy. Patients who received the indication for endoscopic diagnostics using gastroscopy in transnasal technique will be included into the study. The examination is carried out in standard technique and is not influenced by the study. Following the examination, patient data is collected pseudonymously and a questionnaire is sumbitted to the patient. Only patients who have the indication for gastroscopy in transnasal technique are included. A specific risk to patients cannot be foreseen.This study does not interfere with diagnostics or therapy.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date December 31, 2021
Est. primary completion date June 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Indication for transnasal endoscopy Exclusion Criteria: - pregnancy - breast feeding - contraindication to transnasal endoscopy - pronounced blood clotting disorders

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• gastroscopy in transnasal techique
All patients with indication for gastroscopy in transnasal technique are included.

Locations
Country Name City State
Germany University Hospital Mainz Mainz Rhenanie-Palatinate

Sponsors (1)
Lead Sponsor Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Questionnaire a questionnaire with 5 questions regarding the quality of the examination, technique and safety is presented to the patients after examination, about 15 minutes
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