Droplet SpreadNCT04864015
COVID-19 Aerosol in EGD Using a Droplet Reduction Mouthpiece
A study testing Mouthpiece B1(Mouthpiece MPC-ST GMDN:62534 Generic name: Endoscopic bite block, basic, reusable in people with Droplet Spread and Covid19, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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'. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Droplet Spread, Covid19
- What is being tested?
- Mouthpiece B1(Mouthpiece MPC-ST GMDN:62534 Generic name: Endoscopic bite block, basic, reusable
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Mar 2021to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Females who are pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19: a Study About Aerosol Formation During Gastroscopy With a Adjusted Mouthpiece for Droplet Reduction
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.
Read the 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
- Conditions
- Droplet Spread, Covid19
- Being tested
- Mouthpiece B1(Mouthpiece MPC-ST GMDN:62534 Generic name: Endoscopic bite block, basic, reusable
- Keywords
- droplet reduction mask, COVID-19, upper GI endoscopy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouthpiece B1(Mouthpiece MPC-ST GMDN:62534 Generic name: Endoscopic bite block, basic, reusableDevice
Use of a Mouthpiece B1 during standard EGD instead of a conventional mouthpiece
| Study group | Role | What they receive |
|---|---|---|
| Conventional mouthpiece | Placebo comparator | Patients undergoing standard EGD using a conventional mouthpiece Receives: Device: Mouthpiece B1(Mouthpiece MPC-ST GMDN:62534 Generic name: Endoscopic bite block, basic, reusable |
| Droplet reduction mouthpiece | Active comparator | Patients undergoing standard EGD using a new droplet reduction mouthpiece Receives: Device: Mouthpiece B1(Mouthpiece MPC-ST GMDN:62534 Generic name: Endoscopic bite block, basic, reusable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generation of aerosol particles by esophagogastroduodenoscopy with the droplet reduction mouthpiece.
Number of aerosols generated by EGD with the droplet reduction mouthpiece
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start17 Mar 2021
- Primary completion15 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Droplet SpreadStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A investigator-initiated single center open-label randomized trial
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Tack, MD, PhD, Principal investigator, UZ Leuven, KU LeuvenRaf Bisschops, MD, PhD, Principal investigator, UZ Leuven, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864015
- Sponsor's protocol ID
- s65197
- Status last verified
- Oct 2021
- First submitted
- 27 Apr 2021
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We won't share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19: a Study About Aerosol Formation During Gastroscopy With a Adjusted Mouthpiece for Droplet Reduction
- ClinicalTrials.gov ID
- NCT04864015
- Acronym / sponsor ID
- s65197
- Conditions
- Droplet Spread, Covid19
- Keywords
- droplet reduction mask, COVID-19, upper GI endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A investigator-initiated single center open-label randomized trial
| Arm | Type | Receives |
|---|---|---|
| Conventional mouthpiece | Placebo comparator | Device: Mouthpiece B1(Mouthpiece MPC-ST GMDN:62534 Generic name: Endoscopic bite block, basic, reusablePatients undergoing standard EGD using a conventional mouthpiece |
| Droplet reduction mouthpiece | Active comparator | Device: Mouthpiece B1(Mouthpiece MPC-ST GMDN:62534 Generic name: Endoscopic bite block, basic, reusablePatients undergoing standard EGD using a new droplet reduction mouthpiece |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- Females who are pregnant or lactating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mouthpiece B1(Mouthpiece MPC-ST GMDN:62534 Generic name: Endoscopic bite block, basic, reusableUse of a Mouthpiece B1 during standard EGD instead of a conventional mouthpiece | Device | Conventional mouthpiece, Droplet reduction mouthpiece |
Primary outcome
Generation of aerosol particles by esophagogastroduodenoscopy with the droplet reduction mouthpiece.
Time frame: 4 months
Number of aerosols generated by EGD with the droplet reduction mouthpiece
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: No. We won't share individual participant data
Related trials for Droplet Spread
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Influenza (Healthy Volunteers)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Tack, MD, PhD principal investigator
UZ Leuven, KU Leuven
Raf Bisschops, MD, PhD principal investigator
UZ Leuven, KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mouthpiece B1(Mouthpiece MPC-ST GMDN:62534 Generic name: Endoscopic bite block, basic, reusable in people with Droplet Spread and Covid19, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generation of aerosol particles by esophagogastroduodenoscopy with the droplet reduction mouthpiece. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.