At a glance

ClinicalIndex Comparison Record

N/ACompleted· 24 enrolled

Drug / intervention

PillCam UGI +1 moredevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03458000

NCT03458000N/ACompleted

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Capsule Endoscopy for Hemorrhage in the ER

George Washington University·interventional·Posted Mar 8, 2018·Updated Jun 1, 2023

In Brief

A clinical study evaluating PillCam UGI and Standard of Care for Upper Gastrointestinal Bleeding. Completed, enrolled 24 participants across 3 sites.

Detailed Summary

This is a multi-center randomized controlled trial examining the use of Video Capsule Endoscopy (VCE) to discharge low-moderate risk patients with suspected upper gastrointestinal bleeds (UGIB) from the Emergency Department (ED.) The investigators will enroll 100 subjects at 4 sites who present with signs of hemodynamically stable UGIBs and compare VCE risk assessment to an Active Control (AC) group who receive inpatient upper endoscopy (EGD).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsUpper Gastrointestinal Bleeding

CountriesUnited States

CollaboratorsMedtronic

Timeline

N/ACompletedFinished

201820192020202120222023202420252026

First PostedMar 2018

Enrollment StartApr 2018

Primary CompletionMar 2020

Study CompletionSep 2020

TodayJul 2026

First PostedMar 8, 2018

Enrollment StartApr 17, 2018

Primary CompletionMar 15, 2020

Study CompletionSep 7, 2020

TodayJul 2, 2026

Enrollment to primary: 1.9 yearsPosted 8.3 years ago

Interventions

PillCam UGIdevice

An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract.

Standard of Careother

Patient was admitted to hospital for care and received in-patient EGD.