Evaluation of Transnasal Endoscopy During COVID-19 Pandemic

NCT ID: NCT04734912

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-13
• Study Completion Date: 2021-12-31

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.

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.

Conditions

Endoscopy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Gastroscopy in transnasal technique

All patients with indication for gastroscopy in transnasal techqiue are included.

Group Type: OTHER

gastroscopy in transnasal techique

Intervention Type: OTHER

All patients with indication for gastroscopy in transnasal technique are included.

Interventions

gastroscopy in transnasal techique

All patients with indication for gastroscopy in transnasal technique are included.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Indication for transnasal endoscopy

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: lead

Responsible Party

Prof. Helmut Neumann

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helmut Neumann, M.D. PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Mainz

Locations

University Hospital Mainz

Mainz, Rhenanie-Palatinate, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Helmut Neumann, M.D. PhD

Role: CONTACT

helmut.neumann@unimedizin-mainz.de

+49 (0) 6131 ext. 176838

Tanja Bender, M.A.

Role: CONTACT

tanja.bender@unimedizin-mainz.de

+49 (0) 6131 ext. 176838

Facility Contacts

Prof. Helmut Neumann, M.D. PhD

Role: primary

helmut.neumann@unimedizin-mainz.de

+49 (0) 6131 ext. 176838

Tanja Bender, M.A:

Role: backup

tanja.bender@unimedizin-mainz.de

+49 (0) 6131 ext. 176838

Other Identifiers

ETNE v1.0

Identifier Type: -

Identifier Source: org_study_id