18 and older, any sex, with Infectious or Gastro-Intestinal Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Aerosolization of Particles During Upper EndoscopyPrimary· 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.
less than 0.3 μm
Group
Value
95% CI
Endoscopic Facemask
9.86
9.62 – 10.1
No Endoscopic Facemask
9.87
9.65 – 10.1
0.3- 0.5 μm
Group
Value
95% CI
Endoscopic Facemask
6.93
6.66 – 7.21
No Endoscopic Facemask
7.05
6.8 – 7.31
0.5- 0.7 μm
Group
Value
95% CI
Endoscopic Facemask
5.63
5.32 – 5.93
No Endoscopic Facemask
5.49
5.19 – 5.78
0.7- 1.0 μm
Group
Value
95% CI
Endoscopic Facemask
6.33
6.1 – 6.57
No Endoscopic Facemask
6.34
6.12 – 6.56
1.0- 5.0 μm
Group
Value
95% CI
Endoscopic Facemask
4.73
4.62 – 4.84
No Endoscopic Facemask
4.74
4.63 – 4.84
5.0 - 10 μm
Group
Value
95% CI
Endoscopic Facemask
4.78
4.68 – 4.88
No Endoscopic Facemask
4.71
4.61 – 4.8
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Anthony Lembo
Last refreshed: 13 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06006078.