COVID-19: a Study About Aerosol Formation During Gastroscopy With a Adjusted Mouthpiece for Droplet Reduction
Phase: NA
Conditions: Droplet Spread, Covid19
Sponsor: Universitaire Ziekenhuizen KU Leuven

 
 
1 
 
 
Protocol Full Title prospective trial: COVID-19: The study of aerosol 
generation 
with 
the 
droplet 
reduction 
mouthpiece 
during 
esophagogastroduodenoscopy 
Protocol Acronym/short title: aerosols generation with modified mouthpiece in 
EGD (S65197) 
Version and date of final protocol: version 2 – 04MAR2021 
Sponsor: UZLeuven 
Address: Herestraat 49, 3000 Leuven 
 
Principal Investigators: 
 
Name: 
 
Prof. Jan Tack 
Address:  
Herestraat 49, box 701, 3000 Leuven 
Telephone: 
+32 (0)16 330816  
Email: 
 
jan.tack@kuleuven.be 
 
 
Name:  
 
Prof. Raf Bisschops 
Address:  
Herestraat 49, box 701, 3000 Leuven 
Email: 
 
raf.bisschops@uzleuven.be 
 
 
Sub-investigator: 
 
Name:  
 
Dr. I-Hsuan Huang 
Address:  
Herestraat 49, box 701, 3000 Leuven 
Email: 
 
ihsuan.huang@kuleuven.be 
 
Name:  
 
Dr. Pieter Sinonquel 
Address:  
Herestraat 49, box 701, 3000 Leuven 
Email: 
 
pieter.sinonquel@kuleuven.be 
 
Name:  
 
Kristof Buysschaert 
Address:  
Herestraat 49, box 701, 3000 Leuven 
Email: 
 
kristof.buysschaert@uzleuven.be 
 
Name:  
 
Hilde Willekens 
Address:  
Herestraat 49, box 701, 3000 Leuven 
Email: 
 
Hilde.Willekens@uzleuven.be 
 
Name:  
 
Herman Devriese 
Address:  
Herestraat 49, box 701, 3000 Leuven 
Email: 
 
herman.devriese@uzleuven.be 

 
 
2 
 
Signatures 
 
 
Jan Tack 
 
 
_________________________ 
 
 
 
____________________ 
Principal Investigator  
 
 
 
 
Date 
 
 
Raf Bisschops 
 
 
_________________________ 
 
 
 
____________________ 
Principal Investigator  
 
 
 
 
Date 
 
 
I-Hsuan Huang 
 
 
_________________________ 
 
 
 
____________________ 
Sub-investigator 
 
 
 
 
 
Date 
 
 
Pieter Sinonquel 
 
 
_________________________ 
 
 
 
____________________ 
Sub-investigator 
 
 
 
 
 
Date 
 
 
Hilde Willekens 
 
_________________________ 
 
 
 
____________________ 
Sub-investigator 
 
 
 
 
 
Date 

 
 
3 
 
 
Kristof Buysschaert 
 
_________________________ 
 
 
 
____________________ 
Sub-investigator 
 
 
 
 
 
Date 
 
 
Herman Devriese 
 
_________________________ 
 
 
 
____________________ 
Sub-investigator 
 
 
 
 
 
Date 
 
 
 

 
 
4 
 
Table of Contents 
1. 
Study Synopsis ............................................................................................................................. 6 
2. 
Background and rationale ........................................................................................................... 7 
3. 
Trial objectives and Design ......................................................................................................... 8 
3.1 
Trial objectives .................................................................................................................. 8 
3.2 
Primary endpoints ............................................................................................................. 8 
3.3 
Secondary endpoints ....................................................................................................... 8 
3.4 Trial Design ............................................................................................................................. 9 
3.5 Trial Flowchart ........................................................................................................................ 9 
4 Selection and withdrawal of subjects ............................................................................................. 9 
4.1 Inclusion criteria ..................................................................................................................... 9 
4.2 Exclusion criteria .................................................................................................................. 10 
4.3 Expected duration of trial .................................................................................................... 10 
5. 
Trial Procedures .......................................................................................................................... 10 
5.1 
Preparation room and patient ....................................................................................... 10 
5.1.1 
Room ............................................................................................................................ 10 
5.1.2 
Patient........................................................................................................................... 10 
5.2 
Esophagogastroduodenoscopy .................................................................................... 11 
6 
Assessment of aerosol generation ........................................................................................... 11 
7    Safety reporting ............................................................................................................................ 11 
7.1 
Definitions ........................................................................................................................ 11 
7.1.1 Adverse Event (AE) .......................................................................................................... 11 
7.1.2 Adverse Reaction (AR) .................................................................................................... 12 
7.1.3 Serious Adverse Event (SAE) ......................................................................................... 12 
7.2 
Adverse Events that do not require reporting ............................................................. 12 
7.3 
Recording and reporting of Adverse Events ............................................................... 13 
7.3.1 
Assessment ................................................................................................................. 13 
7.3.2 
Timelines for reporting ............................................................................................... 14 
7.3.3 
Follow-up ...................................................................................................................... 15 
7.3.4 
Pregnancy .................................................................................................................... 15 

 
 
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7.3.5 
Death ............................................................................................................................ 16 
7.4 Reporting requirements to Ethics Committee’s (EC’s) and Competent Authorities 
(CA’s) ............................................................................................................................................ 16 
7.4.2 
Annual reporting .......................................................................................................... 16 
7.4.3 
Overview reporting requirements ............................................................................. 17 
8 
Statistics ....................................................................................................................................... 17 
8.1 
Sample size ..................................................................................................................... 17 
9 
Quality assurance ....................................................................................................................... 18 
10 
Direct access to source data and documents .................................................................... 18 
11 
Ethics and regulatory approvals ........................................................................................... 18 
12 
Data Handling .......................................................................................................................... 19 
13 
Data Management .................................................................................................................. 19 
14 
Translational research ........................................................................................................... 19 
15 
Publication Policy .................................................................................................................... 20 
16 
Insurance/Indemnity ............................................................................................................... 20 
17 
Financial Aspects .................................................................................................................... 20 
18 
References .............................................................................................................................. 21 
 
 
 

 
 
6 
 
1. Study Synopsis  
Title of clinical trial 
The study of aerosol generation with the droplet 
reduction mouthpiece during 
esophagogastroduodenoscopy 
Principal Investigator 
Prof. Dr. Jan Tack 
Medical condition or disease under 
investigation 
Aerosol generation with the droplet reduction mouthpiece
during endoscopy procedures 
Purpose of clinical trial 
To investigate the effect of droplet reduction 
mouthpiece on aerosol particle generation during 
esophagogastroduodenoscopy 
Primary objective 
Generation of aerosol particles by 
esophagogastroduodenoscopy with the droplet reduction 
mouthpiece 
Secondary objective (s) 
None 
Trial Design 
Prospective interventional study 
Sample Size 
80 patients undergoing elective upper GI endoscopy 
Summary of eligibility criteria 
Patients undergoing elective upper gastrointestinal 
endoscopy 
Maximum duration of treatment of a subject 
Not applicable  
Version and date of final protocol 
Version 2: 04 March 2021 
Version and date of protocol amendments 
Not Applicable 
 
 
 

 
 
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2. Background and rationale 
 
Gastrointestinal (GI) endoscopy is one of the most commonly performed invasive procedures 
in clinical practice. Health care workers (HCW) at the endoscopy unit are at constant 
occupational risk for many infectious diseases as they perform daily procedures that are 
believed to generate aerosol and droplets, which may harvest respiratory pathogens. The size 
of particles determines the time of suspension in air and the distance of transmission. 
Currently, droplets are defined by a particle size larger than 5 µm in diameter while particles 
below 5 µm diameter are referred to as aerosols (1). Generally, all endoscopic procedures are 
considered potentially aerosol generating (2). Current guidelines recommend using high-level 
protection with N95 mask, FFP2 or FFP3, gloves, face shield and gown for high-risk patients 
during endoscopic procedures (3, 4). A growing number of scientific reports confirm that 
esophagogastroduodenoscopy is an aerosol-generating procedure (5, 6). A number of 
approaches to decrease the amount of aerosol generated have been reported including, for 
instance, the use of dental sucker in the oral cavity for continuous suction during the procedure 
or placing patients with their heads covered by a plastic enclosure, “endoscopic shield” (5, 6). 
Nevertheless, either use of the dental sucker or endoscopic shield may be less comfortable 
for patients and requires time and personnel and may therefore also be inconvenient for HCW.  
 
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 HCW 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 GI endoscopy is being performed. 

 
 
8 
 
 
The aim of the present study is to quantify the generation of aerosols when performing upper 
GI endoscopy with the modified mouthpiece. We 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, we are limiting the protocol 
to standard diagnostic EGDs. We assume that aerosol generations during short procedures 
can be extrapolated to longer procedures and hence this should not invalidate the findings. 
 
 
3. Trial objectives and Design 
3.1 Trial objectives 
To perform a study to quantify the number of aerosol generation during EGD, using the droplet 
reduction mouthpiece, in the phases of COVID-19 pandemic.  
 
3.2 Primary endpoints 
Generation of aerosol particles by esophagogastroduodenoscopy with the droplet reduction 
mouthpiece. 
3.3 Secondary endpoints 
None 

 
 
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3.4 Trial Design 
 
3.5 Trial Flowchart 
Study Procedures 
Timing 
PCR testing on nasopharyngeal swab 24 hours prior to the test performed and 
negative 
Day -2 or day -1 
Informed consent 
Day -2, -1 or Day 0 
EGD 
Day 0 
Measurement of aerosol generation 
Day 0  
 
 
4 Selection and withdrawal of subjects 
4.1 Inclusion criteria 
 
Aged >18 years old; 
 
Male or female patients; 
 
Patients undergoing elective standard diagnostic EGD; 
 
Negative PCR 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. 

 
 
10 
 
 
4.2 Exclusion criteria 
 
Females who are pregnant or lactating. 
 
4.3 Expected duration of trial 
The duration of this protocol is estimated at 3 months. 
 
4.4 Recruitment of subjects  
 
Patients are recruited from the gastroenterology clinic at the University Hospitals Leuven. 
Patients undergoing elective EGD will be invited to participate in the study.  
 
5. Trial Procedures 
5.1 Preparation room and patient 
5.1.1 
Room 
The room is also equipped with an air particle counter (Lasair particle measure counter). A 
plastic tube, connected to the inlet of the counter, is placed within 10 cm from the mouth of the 
patient once the patient is set up in the room. The counter takes 1-minute air samples to 
quantify particles of 0.3, 0.5, 0.7, 1, 5 and 10 µm (6). Measurements of particle counts occur 
right before the endoscope insertion and 1, 3, 5, 10 and 15 minutes after the start of 
endoscopy, as well as after the completion of endoscopy. If the endoscopy is terminated before 
all measurements are done, the remaining measurements at time point 10 minutes and/or 15 
minutes will be dropped. 
5.1.2 
Patient 
Before the investigations, all patients need to have a negative SARS-CoV-2 test. Eligible 
patients will be randomly assigned to one of the following groups: the group using the droplet 
reduction mouthpiece, or the group using the conventional mouthpiece for EGD. 
Randomization 
will 
be 
generated 
via 
an 
online 
randomization 
program 
(www.randomization.com). 

 
 
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5.2 Esophagogastroduodenoscopy 
A conventional gastrointestinal videoscope will be orally inserted into the stomach to observe 
the upper gastrointestinal tract. During the examination, patients will be placed on their left 
side. EGD for all patients will be performed by one endoscopist and one assistant nurse. 
Premedication with anticholinergic agents or glucagon will not be used. Lidocaine (8%) will be 
sprayed into the posterior pharynx of all patients before insertion of the endoscope to reduce 
the gag reflex. Then, midazolam (0-5 mg) and pethidine (0-50 mg) can be administered 
intravenously for sedation, depending on the expected difficulty of the procedure and the 
anxiety level of the patient. Adequate monitoring of vital signs and oxygen saturation is 
performed throughout the examination.  
6 Assessment of aerosol generation 
Particle counts per cubic feet for each particle size will be measured prior to start of the 
procedure, and 1, 3, 5, 10 and 15 minutes after the start of endoscopy, as well as after the 
completion of endoscopy. If the endoscopy is terminated before all measurements are done, 
the remaining measurements at time point 10 minutes and/or 15 minutes will be dropped. The 
primary outcome will be to assess the changes of aerosols before, during, and after endoscopy 
and compare their trends in using droplet reduction mouthpiece and conventional mouthpiece 
groups. The changes in particle counts over time will be described and a random effect of 
repeated measures will be used in models to examine the effect of new mouthpiece. 
7    Safety reporting 
At the study visit, the investigator will determine whether any adverse events have occurred. 
The patient will be questioned in a general way and no specific symptoms will be suggested. 
If any adverse events have occurred, they will be recorded and we will act accordingly.  
Since this is an Investigator driven study, the Sponsor is the Investigator and it should be 
interpreted as such.  
7.1 Definitions 
7.1.1 Adverse Event (AE) 
An AE is any untoward medical occurrence in a patient or subject during an experiment, and 
which does not necessarily have a causal relationship with this treatment. 

 
 
12 
 
An AE can therefore be any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom or disease temporally associated with the use of a product, 
whether or not considered related to the product. Any worsening (i.e., any clinically significant 
adverse change in the frequency or intensity of a pre-existing condition) should be considered 
an AE. 
7.1.2 Adverse Reaction (AR) 
An AR is any untoward and unintended responses to an investigational medicinal product or 
to an experiment and, when an investigational product is concerned, related to any dose 
administered. 
7.1.3 Serious Adverse Event (SAE) 
An SAE is any untoward medical occurrence that results in any of the following: 
 
Death 
 
A life-threateninga experience 
 
In-patient hospitalisation or prolongation of existing hospitalisation 
 
A persistent or significant disability or incapacity 
 
A congenital anomaly or birth defect 
 
Important medical events that may be considered an SAE when - based on appropriate 
medical judgement - they may jeopardise the subject and may require medical or 
surgical intervention to prevent one of the above outcomes 
 
a The term “life threatening” in the definition of SAE refers to an event in which the subject was at risk of death 
at the time of the event. It does not refer to an event which hypothetically might have caused death if it was 
more severe. 
7.2 Adverse Events that do not require reporting 
In general, the following should not be reported as AEs: 
 
Pre-existing conditions, including those found as a result of screening (these should be 
reported as medical history or concomitant illness). 
 
Pre-planned procedures unless the condition for which the procedure was planned has 
worsened from the first trial-related activity after the subject has signed the informed 
consent. 

 
 
13 
 
Only events related to the study-specific intervention will be reported in the (e)CRF.  
The following events not to be considered as SAEs are: 
 
Pre-planned hospitalisations unless the condition for which the hospitalisation was 
planned has worsened from the first trial-related activity after the subject has signed 
the informed consent.  
 
Hospitalisation as part of a standard procedure for protocol therapy administration. 
However, hospitalisation or prolonged hospitalisation for a complication of therapy 
administration will be reported as an SAE. 
 
Hospitalisation or prolongation of hospitalisation for technical, practical, or social 
reasons, in absence of an AE. 
7.3 Recording and reporting of Adverse Events 
Investigators will seek information on AEs during each patient contact. If related to the study-
specific intervention, whether reported by the patient or noted by trial staff, will be recorded in 
the patient’s medical record and in the (e)CRF within a reasonable time after becoming aware. 
If available, the diagnosis should be reported on the AE page, rather than the individual signs 
or symptoms. If no diagnosis is available, the Investigator should record each sign and 
symptom as individual AEs. 
The following minimum information should be recorded for each AE: 
- AE description 
- start and stop date of the AE 
- severity 
- seriousness 
- causality assessment to the study interventions 
- outcome 
7.3.1 Assessment  
All AEs must be evaluated by an Investigator as to: 
 
Seriousness: whether the AE is an SAE. See above for the seriousness criteria. 
 
Severity:  

 
 
14 
 
o Severity must be evaluated by an Investigator according to the following 
definitions: 
 
Mild – no or transient symptoms, no interference with the subject’s daily 
activities 
 
Moderate – marked symptoms, moderate interference with the subject’s 
daily activities 
 
Severe – considerable interference with the subject’s daily activities, 
unacceptable 
 
Causality: 
 
None – An AE which is not related to the study-related interventions 
 
Unlikely – An AE for which an alternative explanation is more likely (e.g. 
concomitant medication(s), concomitant disease(s)), and/or the relationship in 
time suggests that a causal relationship is unlikely 
 
Possible – An AE which might be due to the study-related interventions. An 
alternative explanation is inconclusive. The relationship in time is reasonable; 
therefore the causal relationship cannot be ruled out. 
 
Probable - An AE which might be due to the study-related intervention. The 
relationship in time is suggestive (e.g. confirmed by dechallenge). An alternative 
explanation is less likely. 
 
Definitely – An AE which is known as a possible adverse reaction and cannot 
be reasonably explained by an alternative explanation. The relationship in time 
is very suggestive (e.g. it is confirmed by dechallenge and rechallenge). 
 
7.3.2 Timelines for reporting 
After informed consent has been obtained and after initiation of study-related interventions:  
o If related to the study-specific intervention AEs and SAEs causally related to a 
study-related intervention will be reported until 30 days after the last study-
related intervention or until last follow-up visit (whichever occurs first). 
If related to the study-specific intervention SAEs as defined in the protocol must be reported 
to the Sponsor within 24 hours of the trial staff becoming aware of the event. The immediate 

 
 
15 
 
report shall be followed by detailed, written reports. The immediate and follow-up reports shall 
identify subjects by Trial identification. 
 
SAE details will be reported by the Investigator to the Sponsor:  
 
By completing the SAE form in the (e)CRF 
If an authorised Investigator from the reporting site is unavailable, initial reports 
without causality and expectedness assessment should be submitted to the 
Sponsor by a healthcare professional within 24 hours of becoming aware of the 
SAE, but must be followed-up by medical assessment as soon as possible 
thereafter. 
7.3.3 Follow-up  
The Investigator must record follow-up information by updating the medical records and the 
appropriate forms in the (e)CRF. The worst case severity and seriousness of an event must 
be kept throughout the trial. 
SAE follow-up information should only include new (e.g. corrections or additional) information 
and must be reported within 24 hours of the Investigator’s first knowledge of the information. 
This is also the case for previously non-serious AEs which subsequently become SAEs. 
 
All SAEs must be followed up until the outcome of the event is ‘recovered’, ‘recovered 
with sequelae’, ‘not recovered’ (in case of death due to another cause) or ‘death’ (due 
to the SAE) and until all related queries have been resolved, or until end of trial 
(whichever occurs first). 
 
Non-serious AEs must be followed up until the patient’s last study visit, and until all 
related queries have been resolved. 
 
SAEs after the end of the trial: If the Investigator becomes aware of an SAE with suspected 
causal relationship to the study-related interventions after the subject has ended the trial, the 
Investigator should report this SAE within the same timelines as for SAEs during the trial. 
7.3.4 Pregnancy 
NA 

 
 
16 
 
7.3.5 Death 
All deaths will be reported without delay to the Sponsor (irrespective of whether the death is 
related to disease progression, study procedure or is an unrelated event). The sponsor will 
notify all deaths, as soon as possible after becoming aware, to the Central EC and the EC of 
the concerned site and provide additional information if requested. 
Reporting requirements to Ethics Committee’s (EC’s) The Investigator is responsible for 
ensuring that all safety events are recorded in the (e)CRF and reported to the Sponsor in 
accordance with instructions provided below. 
The Sponsor will promptly evaluate all SAEs against medical experience to identify and 
expeditiously communicate possible new safety findings to Investigators and based on 
applicable legislation. 
 
7.4 Reporting requirements to Ethics Committee’s (EC’s) and Competent Authorities 
(CA’s)  
The Investigator is responsible for ensuring that all safety events are recorded in the (e)CRF.  
The Investigator will promptly evaluate all SAEs and AESIs against medical experience to 
identify and expeditiously communicate possible new safety findings to Investigators, EC’s and 
applicable CA’s based on applicable legislation. 
 
7.4.2 Annual reporting 
The sponsor has the obligation to, once a year throughout the clinical trial (or on request), 
submit a progress report to the EC’s containing an overview of all SARs occurred during the 
reporting period and taking into account all new available safety information received during 
the reporting period. 
 
 
 
 

 
 
17 
 
7.4.3 Overview reporting requirements 
 
 
WHAT 
 
HOW 
TO 
TIMELINES 
Investigator 
AE 
 
AE form 
sponsor 
as defined in protocol 
SAE 
 
SAE form 
sponsor 
Immediately 
(within 
24 
hours 
of 
becoming aware of 
the event) 
Exceptions: as 
defined in protocol 
death 
 
SAE form 
sponsor 
asap 
Sponsor 
death 
 
SAE form + 
narrative 
Ethics Committees 
asap 
Annual Progress 
Report 
 
APR template 
Ethics Committees 
annually 
AE = adverse event; SAE = serious adverse event; asap = as soon as possible; SUSAR = 
suspected unexpected serious adverse reaction; CIOMS = council for international 
organization of medical sciences; EC = ethics committee; CA = competent authority; DSUR = 
development safety update report; APR = annual progress report; ASR = annual safety 
report 
 
8 Statistics 
8.1 Sample size 
The aim is to create a descriptive review on the aerosol contamination with the droplet 
reduction mouthpiece during endoscopy. As this is a descriptive analysis, no formal power 
calculation was performed. In total we will include 40 patients for endoscopy with the droplet 
reduction mouthpiece and 40 patients for endoscopy with the conventional mouthpiece. 
However, based on previous publications on aerosol generation with nasogastric intubation (7)  

 
 
18 
 
and on reduction of aerosol spread during upper endoscopy with a dental sucker (8), we 
consider this number adequate. 
 
9 Quality assurance 
Patient recruitment follows international consensus diagnostic standards. The aerosol 
counting device will be calibrated prior to and at 4-week intervals throughout the study.  
 
10 Direct access to source data and documents 
The investigator(s) and the institution will permit trial-related monitoring, audits, EC review and 
regulatory inspections (where appropriate) by providing direct access to source data and other 
documents (I.e. patients’ case sheets, blood test reports, histology reports etc). 
 
11 Ethics and regulatory approvals 
The trial will be conducted in compliance with the principles of the Declaration of Helsinki 
(current version), the principles of GCP and in accordance with all applicable regulatory 
requirements. This protocol and related documents will be submitted for review to Ethics 
Committee of the University Hospitals Leuven and any subsequent protocol amendments 
will be submitted to this EC for approval. 
The study can and will be conducted only on the basis of prior informed consent by the 
Subjects, or their legal representatives, to participate in the Study. The Participating Site 
shall obtain a signed informed consent form (ICF) for all patients prior to their enrollment 
and participation in the Study in compliance with all applicable laws, regulations and the 
approval of the Ethics Committee, if required. The Participating Site shall retain such ICFs 
in accordance with the requirements of all applicable regulatory agencies and laws. 
The Investigator and the Participating Site shall treat all information and data relating to 
the Study disclosed to Participating Site and/or Investigator in this Study as confidential 
and shall not disclose such information to any third parties or use such information for any 
purpose other than the performance of the Study. The collection, processing and 
disclosure of personal data, such as patient health and medical information is subject to 
compliance with applicable personal data protection and the processing of personal data 

 
 
19 
 
(Directive 95/46/EC and Belgian law of December 8, 1992 on the Protection of the Privacy 
in relation to the Processing of Personal Data) 
When data are coded, there continues to be a link between the data and the individual 
who provided it. The research team is obligated to protect the data from disclosure outside 
the research according to the terms of the research protocol and the informed consent 
document. The subject’s name or other identifiers should be stored separately from their 
research data and replaced with a unique code to create a new identity for the subject. 
Note that coded data are not anonymous. 
 
12 Data Handling 
Data will be collected and analyzed by the study investigators (I-Hsuan Huang) of the 
Translational Research Center for Gastrointestinal Disorders (TARGID), Department of 
Clinical and Experimental Medicine and University Hospitals Leuven.  
 
Principal Investigator:  
Jan Tack, MD, PhD  
Sub-Investigators:  
I-Hsuan Huang, MD 
Pieter Sinonquel, MD 
Kristof Buysschaert, RN 
Hilde Willekens, RN 
Herman Devriese, Ir 
 
13 Data Management 
All collected data will be coded and entered into an eCRF (REDCap).  The access to REDCap 
and exported  files are password protected and will only be granted to selected members of 
the study team. 
 
14 Translational research 
NA 
 

 
 
20 
 
15 Publication Policy 
Publications will be coordinated by the study team. Authorship to publications will be 
determined in accordance with the requirements published by the International Committee of 
Medical Journal Editors and in accordance with the requirements of the respective medical 
journal. 
 
16 Insurance/Indemnity 
In accordance with the Belgian Law relating to experiments on human persons dated May 7, 
2004, Sponsor shall assume, even without fault, the responsibility of any damages incurred by 
a Study Patient and linked directly or indirectly to the participation to the Study, and shall 
provide compensation therefore through its insurance. 
 
17 Financial Aspects 
No additional investigations are needed in this protocol. Patients that participate have already 
planned EGD. Therefore, no additional financial compensation is included in this protocol. 
 
 
 
 
 
 
 
 
 
 

 
 
21 
 
18 References 
1. 
Fennelly KP. Particle sizes of infectious aerosols: implications for infection control. The Lancet 
Respiratory Medicine. 2020. 
2. 
Soetikno R, Teoh AY, Kaltenbach T, Lau JY, Asokkumar R, Cabral-Prodigalidad P, et al. 
Considerations in performing endoscopy during the COVID-19 pandemic. Gastrointestinal endoscopy. 
2020. 
3. 
Sultan S, Lim JK, Altayar O, Davitkov P, Feuerstein JD, Siddique SM, et al. AGA rapid 
recommendations for gastrointestinal procedures during the COVID-19 pandemic. Gastroenterology. 
2020;159(2):739-58. e4. 
4. 
Gralnek IM, Hassan C, Beilenhoff U, Antonelli G, Ebigbo A, Pellisè M, et al. ESGE and ESGENA 
Position Statement on gastrointestinal endoscopy and the COVID-19 pandemic. Endoscopy. 
2020;52(6):483. 
5. 
Sagami R, Nishikiori H, Sato T, Tsuji H, Ono M, Togo K, et al. Aerosols Produced by Upper 
Gastrointestinal Endoscopy: A Quantitative Evaluation. Official journal of the American College of 
Gastroenterology| ACG. 2020;116(1):202-5. 
6. 
Chan SM, Ma TW, Chong MK-C, Chan DL, Ng EKW, Chiu PWY. A proof of concept study: 
Esophagogastroduodenoscopy is an aerosol-generating procedure and continuous oral suction 
during the procedure reduces the amount of aerosol generated. Gastroenterology. 2020. 
7. 
Verbeure W, Geeraerts A, Huang I-H, Timmermans L, Toth J, Geysen H, et al. Aerosol 
generation and droplet spread during nasogastric intubation in the COVID-19 era. Gut. 2020. 
8. 
Chan SM, Ma TW, Chong MK-C, Chan DL, Ng EKW, Chiu PWY. A proof of concept study: 
esophagogastroduodenoscopy is an aerosol-generating procedure and continuous oral suction 
during the procedure reduces the amount of aerosol generated. Gastroenterology. 
2020;159(5):1949-51. e4.