Capsule Endoscopy in Obscure GI Bleeding

NCT ID: NCT00203619

Last Updated: 2017-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2016-09-30

Brief Summary

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The purpose of this study is to conduct a cost-effectiveness analysis of wireless capsule endoscopy in the investigation of patients with overt obscure gastrointestinal bleeding. To inform this analysis, a randomized controlled trial of capsule endoscopy compared with standard care will be conducted

Detailed Description

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The purpose of this study is to conduct a cost-effectiveness analysis of wireless capsule endoscopy in the investigation of patients with overt obscure gastrointestinal bleeding. To inform this analysis, a randomized controlled trial of capsule endoscopy compared with standard care will be conducted. Patients randomized 1:1.

Conditions

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Obscure Gastrointestinal Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Wireless capsule endoscopy

Group Type EXPERIMENTAL

Wireless capsule endoscopy

Intervention Type DEVICE

wire less capsule endoscopy

2

Standard care

Group Type ACTIVE_COMPARATOR

standard care

Intervention Type OTHER

standard diagnostic evaluation as decided by treating physician

Interventions

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Wireless capsule endoscopy

wire less capsule endoscopy

Intervention Type DEVICE

standard care

standard diagnostic evaluation as decided by treating physician

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age 18 or older
2. Obscure overt GI bleeding
3. No cause for bleeding found on Gastroscopy and colonoscopy within 1 week of bleeding

Exclusion Criteria

1. Known or suspected swallowing disorders
2. Known or suspected small bowel obstruction
3. Multiple comorbidities precluding surgery
4. Patients with implantable electromagnetic devices
5. Pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alberta Heritage Foundation for Medical Research

OTHER

Sponsor Role collaborator

Calgary Health Region

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Dr. Robert Hilsden

Associate Professor, Department of Medicine & Research Director, Colon Cancer Screening Centre

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert J Hilsden, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id