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Capsule Endoscopy in Obscure GI Bleeding

Primary Purpose

Obscure Gastrointestinal Bleeding

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Wireless capsule endoscopy
standard care
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obscure Gastrointestinal Bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 or older Obscure overt GI bleeding No cause for bleeding found on Gastroscopy and colonoscopy within 1 week of bleeding Exclusion Criteria: Known or suspected swallowing disorders Known or suspected small bowel obstruction Multiple comorbidities precluding surgery Patients with implantable electromagnetic devices Pregnant women

Sites / Locations

  • University of Calgary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Wireless capsule endoscopy

Standard care

Outcomes

Primary Outcome Measures

sf36
giqli
eq50
diagnostic yield

Secondary Outcome Measures

transfusions

Full Information

First Posted
September 13, 2005
Last Updated
December 1, 2017
Sponsor
University of Calgary
Collaborators
Alberta Heritage Foundation for Medical Research, Calgary Health Region
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1. Study Identification

Unique Protocol Identification Number
NCT00203619
Brief Title
Capsule Endoscopy in Obscure GI Bleeding
Official Title
An Economic Evaluation of Capsule Endoscopy for Obscure Gastrointestinal Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Alberta Heritage Foundation for Medical Research, Calgary Health Region

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obscure Gastrointestinal Bleeding

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Wireless capsule endoscopy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Standard care
Intervention Type
Device
Intervention Name(s)
Wireless capsule endoscopy
Intervention Description
wire less capsule endoscopy
Intervention Type
Other
Intervention Name(s)
standard care
Intervention Description
standard diagnostic evaluation as decided by treating physician
Primary Outcome Measure Information:
Title
sf36
Time Frame
48 weeks
Title
giqli
Time Frame
48 weeks
Title
eq50
Time Frame
48 weeks
Title
diagnostic yield
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
transfusions
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or older Obscure overt GI bleeding No cause for bleeding found on Gastroscopy and colonoscopy within 1 week of bleeding Exclusion Criteria: Known or suspected swallowing disorders Known or suspected small bowel obstruction Multiple comorbidities precluding surgery Patients with implantable electromagnetic devices Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Hilsden, MD PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N1
Country
Canada

12. IPD Sharing Statement

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Capsule Endoscopy in Obscure GI Bleeding

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