Capsule Endoscopy in Obscure GI Bleeding

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of Calgary.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Alberta Heritage Foundation for Medical Research
Calgary Health Region
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00203619
First received: September 13, 2005
Last updated: June 9, 2008
Last verified: June 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: An Economic Evaluation of Capsule Endoscopy for Obscure Gastrointestinal Bleeding

Resource links provided by NLM:


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
Experimental: 1
Wireless capsule endoscopy
Device: Wireless capsule endoscopy
wire less capsule endoscopy
Active Comparator: 2
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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 16, 2014