InfectiousNCT06006078
Aerosolization During Upper Endoscopy
A study testing Endoscopic Patient Facemask in people with Infectious and Gastro-Intestinal Disorder, run by Anthony Lembo at 1 site in United States.
Trial summary
Given the current Covid-19 pandemic alongside the lack of evidence on aerosolization during upper endoscopy the investigators are conducting a randomized controlled trial seeking to assess both the level of aerosolization that occurs during these procedures along with determining if utilization of an endoscopic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious, Gastro-Intestinal Disorder, Safety Issues
- What is being tested?
- Endoscopic Patient Facemask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2021to 15 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing elective upper endoscopic procedures (upper endoscopy, ERCP, endoscopic ultrasound) with monitored anesthesia care at main campus Cleveland Clinic inpatient endoscopy unit.
Who cannot join
- Any patient requiring endotracheal intubation
- Pregnant patients
- Emergency procedures
- Patients who require use of a facemask before or during the procedure due to medical necessity
- Patients under the age of 18
- Non-English speaking individuals
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- Patients unable to provide consent.
- Any procedure done outside the designated procedure room.
- If in the opinion of the anesthesiologist, a subject who was randomized to the control arm requires placement of the procedural mask to augment oxygenation, the subject will be removed from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Use of a Facemask Reduce the Risk of Aerosolization During Anesthesia Assisted Upper Endoscopic Procedures: A Randomized Controlled Trial
Given the current Covid-19 pandemic alongside the lack of evidence on aerosolization during upper endoscopy the investigators are conducting a randomized controlled trial seeking to assess both the level of aerosolization that occurs during these procedures along with determining if utilization of an endoscopic patient face-masks reduces the level of aerosolized particles. The protocol includes the use of a commercially available particle counter the investigators are employing for the measurement of aerosols before, during, and after anesthesia assisted upper endoscopic procedures. The investigators are recruiting patients undergoing these procedures with a target of 30 patients undergoing endoscopy without a facemask and 30 patients undergoing endoscopy with one.
- Conditions
- Infectious, Gastro-Intestinal Disorder, Safety Issues
- Being tested
- Endoscopic Patient Facemask
- Medical subject headings
- Communicable Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Patient FacemaskDevice
Also called POM Mask
A commonly used endoscopic patient facemask that is normally used for oxygen delivery during endoscopy will be tested in this trial as a potential intervention for decreasing particle aerosolization
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Facemask | Active comparator | Patients undergoing endoscopy with the use of an endoscopic facemask Receives: Device: Endoscopic Patient Facemask |
| No Endoscopic Facemask | No intervention | Patients undergoing endoscopy without an endoscopic facemask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerosolization of Particles During Upper Endoscopy
Comparing the aerosolization of particles of six different sizes [0.3μm, 0.5μm, 1μm, 2μm, 5μm and 10μm] during endoscopy between patients using an endoscopic facemask to those without.
Measured: Start of endoscopy through the end of endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start31 Aug 2021
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfectiousStudies of the same condition, open and under way.
- 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
- One group of patients will be randomly assigned to receive an endoscopic facemask and one group of patients will undergo endoscopy without a facemask.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anthony Lembo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anthony Lembo, The Cleveland Clinic
- Investigators
- John Vargo, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006078
- Sponsor's protocol ID
- 21-641
- Status last verified
- Oct 2025
- First submitted
- 16 May 2023
- Last updated
- 13 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Use of a Facemask Reduce the Risk of Aerosolization During Anesthesia Assisted Upper Endoscopic Procedures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06006078
- Acronym / sponsor ID
- 21-641
- Conditions
- Infectious, Gastro-Intestinal Disorder, Safety Issues
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Anthony LemboUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Posted 13 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Given the current Covid-19 pandemic alongside the lack of evidence on aerosolization during upper endoscopy the investigators are conducting a randomized controlled trial seeking to assess both the level of aerosolization that occurs during these procedures along with determining if utilization of an endoscopic patient face-masks reduces the level of aerosolized particles. The protocol includes the use of a commercially available particle counter the investigators are employing for the measurement of aerosols before, during, and after anesthesia assisted upper endoscopic procedures. The investigators are recruiting patients undergoing these procedures with a target of 30 patients undergoing endoscopy without a facemask and 30 patients undergoing endoscopy with one.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group of patients will be randomly assigned to receive an endoscopic facemask and one group of patients will undergo endoscopy without a facemask.
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Facemask | Active comparator | Device: Endoscopic Patient FacemaskPatients undergoing endoscopy with the use of an endoscopic facemask |
| No Endoscopic Facemask | No intervention | –Patients undergoing endoscopy without an endoscopic facemask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing elective upper endoscopic procedures (upper endoscopy, ERCP, endoscopic ultrasound) with monitored anesthesia care at main campus Cleveland Clinic inpatient endoscopy unit.
Key exclusion criteria (9 listed)
- Any patient requiring endotracheal intubation
- Pregnant patients
- Emergency procedures
- Patients who require use of a facemask before or during the procedure due to medical necessity
- Patients under the age of 18
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 |
|---|---|---|
| Endoscopic Patient FacemaskAlso: POM MaskA commonly used endoscopic patient facemask that is normally used for oxygen delivery during endoscopy will be tested in this trial as a potential intervention for decreasing particle aerosolization | Device | Endoscopic Facemask |
Primary outcome
Aerosolization of Particles During Upper Endoscopy
Time frame: Start of endoscopy through the end of endoscopy
Comparing the aerosolization of particles of six different sizes [0.3μm, 0.5μm, 1μm, 2μm, 5μm and 10μm] during endoscopy between patients using an endoscopic facemask to those without.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
John Vargo, MD principal investigator
Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Patient Facemask in people with Infectious and Gastro-Intestinal Disorder, run by Anthony Lembo at 1 site in United States.
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 1 inclusion and 9 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 13 Nov 2025. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 13 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Aerosolization of Particles During Upper Endoscopy (time frame: Start of endoscopy through the end of endoscopy). 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 13 Nov 2025.