COVID-19 Aerosol in EGD Using a Droplet Reduction Mouthpiece

NCT04864015 | Completed

• 1 other identifier: s65197
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Droplet Spread; Covid19

Keywords

droplet reduction mask; COVID-19; upper GI endoscopy

Outcome Measures

Primary Outcomes (1)

• Generation of aerosol particles by esophagogastroduodenoscopy with the droplet reduction mouthpiece.

  Number of aerosols generated by EGD with the droplet reduction mouthpiece

  4 months

Study Arms (2)

Conventional mouthpiece

PLACEBO COMPARATOR

Patients undergoing standard EGD using a conventional mouthpiece

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

Device: Mouthpiece B1(Mouthpiece MPC-ST GMDN:62534 Generic name: Endoscopic bite block, basic, reusable

Interventions

Mouthpiece B1(Mouthpiece MPC-ST GMDN:62534 Generic name: Endoscopic bite block, basic, reusable DEVICE

Use of a Mouthpiece B1 during standard EGD instead of a conventional mouthpiece

Conventional mouthpiece; Droplet reduction mouthpiece

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Females who are pregnant or lactating.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, Flemish Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jan Tack, MD, PhD

  UZ Leuven, KU Leuven

  PRINCIPAL INVESTIGATOR

• Raf Bisschops, MD, PhD

  UZ Leuven, KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A investigator-initiated single center open-label randomized trial

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 28, 2021
• Study Start: March 17, 2021
• Primary Completion: May 15, 2021
• Study Completion: June 30, 2021
• Last Updated: October 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)