Evaluation of Transnasal Endoscopy During COVID-19 Pandemic

January 30, 2021 updated by: Prof. Helmut Neumann, Johannes Gutenberg University Mainz
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Indication for transnasal endoscopy

Exclusion Criteria:

  • pregnancy
  • breast feeding
  • contraindication to transnasal endoscopy
  • pronounced blood clotting disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Gastroscopy in transnasal technique
All patients with indication for gastroscopy in transnasal techqiue are included.
Other: gastroscopy in transnasal techique
All patients with indication for gastroscopy in transnasal technique are included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire
Time Frame: after examination, about 15 minutes
a questionnaire with 5 questions regarding the quality of the examination, technique and safety is presented to the patients
after examination, about 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Investigators

  • Principal Investigator: Helmut Neumann, M.D. PhD, University Medical Center Mainz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 13, 2021

Primary Completion (ANTICIPATED)

June 15, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

January 13, 2021

First Submitted That Met QC Criteria

January 30, 2021

First Posted (ACTUAL)

February 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 30, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETNE v1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

A publication of the results is planned.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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