Trials Sponsors Conditions Drugs Pricing

Conditions

Covid19 Droplet Spread

Keywords

droplet reduction maskCOVID-19upper 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, reusableDevice

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

Conventional mouthpieceDroplet reduction mouthpiece

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Aged \>18 years old;
Male or female patients;

Sponsors & Collaborators

Universitaire Ziekenhuizen KU Leuven
Otherlead

Study Sites (1)

University Hospitals Leuven

Leuven, Flemish Brabant, 3000, Belgium

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

Jan Tack, MD, PhD
UZ Leuven, KU Leuven
PRINCIPAL INVESTIGATOR
Raf Bisschops, MD, PhD
UZ Leuven, KU Leuven
PRINCIPAL INVESTIGATOR

Enrollment

80 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

April 27, 2021

First Posted

April 28, 2021

Study Start

March 17, 2021

Actual (reported)

COVID-19 Aerosol in EGD Using a Droplet Reduction Mouthpiece

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Conventional mouthpiece

Droplet reduction mouthpiece

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Conventional mouthpiece

Droplet reduction mouthpiece

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations