NCT02442830: EDCAP

Comparing Early Capsule Deployment to Current Standard of Care for Management of Gastrointestinal Bleeding

Completed NA Results posted Last updated 7 August 2018

What this trial tests

NA trial testing Early Video Capsule Endoscopy in Melena in 87 participants. Completed in 2 July 2017.

Timeline

19 April 2015

Primary endpoint
2 July 2017

2 July 2017

Quick facts

Lead sponsor	University of Massachusetts, Worcester
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	87
Start date	19 April 2015
Primary completion	2 July 2017
Estimated completion	2 July 2017
Sites	1 location across United States

Drugs / interventions tested

• Early Video Capsule Endoscopy

Conditions studied

• Melena — all drugs for Melena →
• Gastrointestinal Hemorrhage — all drugs for Gastrointestinal Hemorrhage →

Sponsor

University of Massachusetts, Worcester

Who can join

18 and older, any sex, with Melena or Gastrointestinal Hemorrhage. 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.

Time to Localization of Bleeding Primary · Enrollment to localization of bleeding as measured in hours, up to 720 hours, whichever is sooner.

Time to localization of bleeding refers to the time after a patient is admitted to the emergency room and a bleeding source is localized. We defined localization of bleeding as endoscopic visualization of stigmata of recent hemorrhage.

Group	Value	95% CI
Early Video Capsule Endoscopy	21	9 – 31
Standard of Care Workup Group	16	13 – 31

Number of Participants With Localization of Bleeding by the End of Admission Secondary · Patient's will be assessed for the duration of their hospital stay and for thirty days afterwards.

This measurement counts the number of participants with a bleeding source localized by the end of admission.

Group	Value	95% CI
Early Video Capsule Endoscopy	27
Standard of Care Workup Group	15

Sponsor's own description

The objectives of this study are to test whether there are statistically significant differences between the standard of care workup workup of non-hematemesis gastrointestinal bleeding by endoscopy \[upper, lower and other tests\], compared with deployment of a video capsule as the first test followed by the most appropriate endoscopic procedure based on video capsule findings, if needed. The investigators propose to examine differences in time to diagnosis, reduction in numbers of procedures, and length of stay between a standard of care workup protocol and our proposed protocol of early capsule endoscopy deployment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A randomized controlled trial comparing efficacy of early video capsule endoscopy with standard of care in the approach to nonhematemesis GI bleeding (with videos).
   Marya NB, Jawaid S, Foley A, Han S, et al · · 2019 · cited 41× · PMID 29935143 · DOI 10.1016/j.gie.2018.06.016