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COVID-19 Aerosol in EGD Using a Droplet Reduction Mouthpiece

Primary Purpose

Droplet Spread, Covid19

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Mouthpiece B1(Mouthpiece MPC-ST GMDN:62534 Generic name: Endoscopic bite block, basic, reusable
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Droplet Spread focused on measuring droplet reduction mask, COVID-19, upper GI endoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged >18 years old;
  • Male or female patients;
  • Patients undergoing elective standard diagnostic EGD;
  • Negative polymerase chain reaction (PCR) test on nasopharyngeal swab 24 or 48 hours prior to the test;
  • No anatomical deformity of nose and throat, no known diseases of nose and throat;
  • Signed informed consent

Exclusion Criteria:

  • Females who are pregnant or lactating.

Sites / Locations

  • University Hospitals Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Conventional mouthpiece

Droplet reduction mouthpiece

Arm Description

Patients undergoing standard EGD using a conventional mouthpiece

Patients undergoing standard EGD using a new droplet reduction mouthpiece

Outcomes

Primary Outcome Measures

Generation of aerosol particles by esophagogastroduodenoscopy with the droplet reduction mouthpiece.
Number of aerosols generated by EGD with the droplet reduction mouthpiece

Secondary Outcome Measures

Full Information

First Posted
April 27, 2021
Last Updated
October 7, 2021
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT04864015
Brief Title
COVID-19 Aerosol in EGD Using a Droplet Reduction Mouthpiece
Official Title
COVID-19: a Study About Aerosol Formation During Gastroscopy With a Adjusted Mouthpiece for Droplet Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Measurement of aerosolisation during esophagogastroduodenoscopy (EGD) to compare two types of mouthpieces, conventional versus a new and commercially available one 'the droplet reduction mouthpiece B1'. This new mouthpiece is considered to reduce droplet spreading during EGD and therefore could be a good option for use in COVID-19 positive patients.
Detailed Description
During esophagogastroduodenoscopy (EGD), a hard-plastic mouthpiece is used to protect the endoscope from being bitten and to enable its smooth insertion. In September 2020, the droplet reduction Mouthpiece "B1" (Mouthpiece MPC-ST GMDN:62534 Generic name: Endoscopic bite block, basic, reusable) was launched by Fujifilm Corporation, Tokyo, Japan and imported to Europe by Fujifilm Europe. The droplet reduction mouthpiece is used in the same way as the conventional mouthpiece but differs from current mouthpieces by the inclusion of a sponge rubber incorporated into the mouthpiece orifice, and a drape shield specifically created to catch and reduce the droplets emitted by the patient during upper gastrointestinal endoscopy. This newly developed mouthpiece is considered for application during routine endoscopy at our facility during the COVID-19 pandemic, helping to minimize the risk to health care workers and patients from becoming infected with COVID-19 and various other pathogens. However, there is a lack of scientific evidence on the amount of aerosol reduction with the modified mouthpiece when upper gastrointestinal (GI) endoscopy is being performed. The aim of the present study is to quantify the generation of aerosols when performing upper GI endoscopy with the modified mouthpiece. The investigators intend to quantify the number of particles in the air near the patient. The duration of therapeutic upper gastrointestinal endoscopies can vary extremely. To avoid risk of imbalance in procedure durations, the investigational team is limiting the protocol to standard diagnostic EGDs. The investigators assume that aerosol generations during short procedures can be extrapolated to longer procedures and hence this should not invalidate the findings

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Droplet Spread, Covid19
Keywords
droplet reduction mask, COVID-19, upper GI endoscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A investigator-initiated single center open-label randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional mouthpiece
Arm Type
Placebo Comparator
Arm Description
Patients undergoing standard EGD using a conventional mouthpiece
Arm Title
Droplet reduction mouthpiece
Arm Type
Active Comparator
Arm Description
Patients undergoing standard EGD using a new droplet reduction mouthpiece
Intervention Type
Device
Intervention Name(s)
Mouthpiece B1(Mouthpiece MPC-ST GMDN:62534 Generic name: Endoscopic bite block, basic, reusable
Intervention Description
Use of a Mouthpiece B1 during standard EGD instead of a conventional mouthpiece
Primary Outcome Measure Information:
Title
Generation of aerosol particles by esophagogastroduodenoscopy with the droplet reduction mouthpiece.
Description
Number of aerosols generated by EGD with the droplet reduction mouthpiece
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged >18 years old; Male or female patients; Patients undergoing elective standard diagnostic EGD; Negative polymerase chain reaction (PCR) test on nasopharyngeal swab 24 or 48 hours prior to the test; No anatomical deformity of nose and throat, no known diseases of nose and throat; Signed informed consent Exclusion Criteria: Females who are pregnant or lactating.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Tack, MD, PhD
Organizational Affiliation
UZ Leuven, KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raf Bisschops, MD, PhD
Organizational Affiliation
UZ Leuven, KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
State/Province
Flemish Brabant
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We won't share individual participant data

Learn more about this trial

COVID-19 Aerosol in EGD Using a Droplet Reduction Mouthpiece

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