MedTrace Logo

Capsule Endoscopy for HEmorrhage in the ER

NCT03458000 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-06-01

Study results available
· View outcomes & findings →

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).

Conditions

  • Upper Gastrointestinal Bleeding

Interventions

DEVICE

PillCam UGI

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

OTHER

Standard of Care

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

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • George Washington University

    lead OTHER

Principal Investigators

  • Andrew Meltzer, MD · George Washington University- Department of Emergency Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-17
Primary Completion
2020-03-15
Completion
2020-09-07
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03458000 on ClinicalTrials.gov