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Capsule Endoscopy vs Standard of Care for Obscure Intestinal Bleeding

NCT ID: NCT00694954

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

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2016-07-31

Brief Summary

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The role of capsule endoscopy (CE) in patients with obscure / occult gastrointestinal (GI) bleeding remains unclear. This pragmatic randomized controlled trial is designed to determine the diagnostic yield and clinical outcomes of patients with obscure GI bleeding who receive CE compared to those who receive usual standard care.

Detailed Description

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Patients with iron deficiency anemia from suspected occult GI bleeding will be randomized to receive CE or usual standard care following a negative gastroscopy and colonoscopy. Our primary outcome measure (diagnostic yield) and secondary outcome measures (noted below) will be determined after one year of followup. Patients with have a minimum of one year of clinical followup. Direct health care costs in each arm of the study will be determined after a minimum of two years of followup.

An economic evaluation based on the results of the clinical trial is also planned.

Conditions

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Iron Deficiency Anemia

Keywords

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Iron deficiency anemia Wireless capsule endoscopy Obscure-occult 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

Diagnostic Test - Given Imaging Pillcam

Intervention Type DEVICE

Procedure performed once only after randomization. If procedure is incomplete due to a number of variables, procedure may possibly need to be repeated.

Diagnostic possibilities: normal exam, active bleeding, potential source of bleeding (angiodysplasia, ulcer, tumor)

2

Standard Care

Group Type ACTIVE_COMPARATOR

Diagnostics

Intervention Type OTHER

Any other diagnostic tests (if not already performed) that the referring or attending physician deems necessary aside from Wireless Capsule Endoscopy.

Interventions

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Diagnostic Test - Given Imaging Pillcam

Procedure performed once only after randomization. If procedure is incomplete due to a number of variables, procedure may possibly need to be repeated.

Diagnostic possibilities: normal exam, active bleeding, potential source of bleeding (angiodysplasia, ulcer, tumor)

Intervention Type DEVICE

Diagnostics

Any other diagnostic tests (if not already performed) that the referring or attending physician deems necessary aside from Wireless Capsule Endoscopy.

Intervention Type OTHER

Other Intervention Names

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Capsule endoscopy Given Imaging Pillcam Pill camera

Eligibility Criteria

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Inclusion Criteria

1. Adult patients age over 18years with iron deficiency anemia (IDA). IDA is defined as hemoglobin \<137g/L in men or \<120g/L in women with serum ferritin level \<22ug/L in men and \<10ug/L in women.
2. Eligible patients should have a negative gastroscopy and negative colonoscopy within 1 year prior to entry into study.
3. Negative celiac screen and /or negative small bowel biopsies

Exclusion Criteria

1. Overt gastrointestinal bleeding
2. Premenopausal women with menorrhagia
3. Known or suspected small bowel obstruction
4. Serious medical co-morbidities precluding surgery given the risk of capsule impaction
5. Pregnancy
6. Inability to provide informed consent
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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Catherine J. Dube, 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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Internal tracking #1763

Identifier Type: -

Identifier Source: secondary_id

E20270

Identifier Type: -

Identifier Source: org_study_id