Capsule Endoscopy in Obscure GI Bleeding - Full Text View

Sponsor:	University of Calgary
Collaborators:	Alberta Heritage Foundation for Medical Research Calgary Health Region
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00203619

Purpose

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

Condition	Intervention	Phase
Obscure Gastrointestinal Bleeding	Device: Wireless capsule endoscopy Other: standard care	Phase IV

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	An Economic Evaluation of Capsule Endoscopy for Obscure Gastrointestinal Bleeding

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Gastrointestinal Bleeding

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:

sf36 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
giqli [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
eq50 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
diagnostic yield [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

transfusions [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	May 2005
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Wireless capsule endoscopy	Device: Wireless capsule endoscopy wire less capsule endoscopy
2: Active Comparator Standard care	Other: standard care standard diagnostic evaluation as decided by treating physician

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203619

Locations

Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N4N1

Sponsors and Collaborators

University of Calgary

Alberta Heritage Foundation for Medical Research

Calgary Health Region

Investigators

Principal Investigator:

Robert J Hilsden, MD PhD

University of Calgary

More Information

No publications provided

Responsible Party:	University of Calgary ( Robert Hilsden )
Study ID Numbers:	1
Study First Received:	September 13, 2005
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00203619 History of Changes
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Pathologic Processes
Digestive System Diseases
Gastrointestinal Diseases
Gastrointestinal Hemorrhage
Hemorrhage

ClinicalTrials.gov processed this record on February 08, 2010