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Evaluation of Transnasal Endoscopy During COVID-19 Pandemic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04734912
Recruitment Status : Recruiting
First Posted : February 2, 2021
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Prof. Helmut Neumann, Johannes Gutenberg University Mainz

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Endoscopy Other: gastroscopy in transnasal techique Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: all patients with indication für gastroscopy in transnasal techique are included.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of Transnasal Endoscopy During COVID-19 Pandemic
Actual Study Start Date : January 13, 2021
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Indication for transnasal endoscopy

Exclusion Criteria:

  • pregnancy
  • breast feeding
  • contraindication to transnasal endoscopy
  • pronounced blood clotting disorders
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04734912


Contacts
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Contact: Helmut Neumann, M.D. PhD +49 (0) 6131 ext 176838 helmut.neumann@unimedizin-mainz.de
Contact: Tanja Bender, M.A. +49 (0) 6131 ext 176838 tanja.bender@unimedizin-mainz.de

Locations
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Germany
University Hospital Mainz Recruiting
Mainz, Rhenanie-Palatinate, Germany, 55131
Contact: Prof. Helmut Neumann, M.D. PhD    +49 (0) 6131 ext 176838    helmut.neumann@unimedizin-mainz.de   
Contact: Tanja Bender, M.A:    +49 (0) 6131 ext 176838    tanja.bender@unimedizin-mainz.de   
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
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Principal Investigator: Helmut Neumann, M.D. PhD University Medical Center Mainz
More Information
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Responsible Party: Prof. Helmut Neumann, Principal Investigator, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT04734912    
Other Study ID Numbers: ETNE v1.0
First Posted: February 2, 2021    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: A publication of the results is planned.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Helmut Neumann, Johannes Gutenberg University Mainz:
gastroscopy
transnasal
nursing
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases