Last reviewed · How we verify

NCT04473456

Combined Simultaneous EGD-colonoscopy Trial (CoSi Endoscopy)

Completed NA Last updated 8 December 2020
What this trial tests

NA trial testing Simultaneous EGD and colonoscopy in Procedure Time in 51 participants. Completed in 23 September 2020.

Timeline
13 June 2020
Primary endpoint
22 September 2020
23 September 2020

Quick facts

Lead sponsorEmuraCenter LatinoAmerica
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposediagnostic
Enrollment51
Start date13 June 2020
Primary completion22 September 2020
Estimated completion23 September 2020
Sites1 location across Colombia

Drugs / interventions tested

Conditions studied

Sponsor

EmuraCenter LatinoAmerica

Who can join

Adults 18 to 80, any sex, with Procedure Time. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The COVID -19 pandemic has reduced endoscopy services to an average of 83% producing a significant economic impact on endoscopy units worldwide. Endoscopy as an aerosol-generating procedure requires endoscopy units to allow 12 cycles of air exchange per hour, equivalent to 20 minutes, between patients, to reduce medical risk exposure. Planning strategies to facilitate economic reactivation of endoscopy services in a responsible manner, maintaining adequate security measures for both patients and healthcare personnel is currently a major challenge. Serial endoscopic interventions as esophagogastroduodenoscopy (EGD) and colonoscopy are commonly performed during the same sedation time. Estimated times for quality inspection in the upper digestive tract and the colon, are 7 and 6 minutes, respectively. In addition, time to reach the cecum and to set up the following procedure increase not only procedure time but SARS-CoV-2 exposure to healthcare personnel. Performing these two procedures simultaneously by two endoscopists would considerably reduce procedure time while increasing the number of patients evaluated in one day, especially in the period of service reactivation. There are no studies comparing simultaneous EGD and colonoscopy procedures and, serial procedures. This study aims to determine differences in procedures times between simultaneous EGD-colonoscopy and conventional serial EGD-colonoscopy as an alternative to improve the number of procedures/hour/unit during the COVID-19 era.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Verify against primary sources

Data sources for this page

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/NCT04473456.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing