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A Pilot and Feasibility Study to Evaluate Capsule Endoscopy

NCT00974701 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-07-31

No results posted yet for this study

Summary

This study is aimed at assessing the capability of the PillCam Platform using the PillCam ESO 2 Capsule in:

* Determining whether there is 1) active bleeding in the Upper gastrointestinal (UGI) tract, 2) identifying the anatomic location of acute overt UGI bleeding, and 3) discriminating a variceal versus non-variceal source of UGI bleeding.

Conditions

  • Upper Gastrointestinal Hemorrhage

Interventions

DEVICE

PillCam ESO2

The capsule to be tested in this proposed study, PillCam ESO 2 capsule Endoscopy, is an improved version with exactly the same dimensions as the current PillCam ESO capsule, both in length and diameter.

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Josheph Sung, MD,PhD · Prince of Wales Hospital, Hong Kong, China

  • Ian Gralnek, MD., PhD. · Rambam Medical Center, Haifa, Israel

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Hong Kong
  • Israel

Study Locations

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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 NCT00974701 on ClinicalTrials.gov