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Capsule Endoscopy in Obscure GI Bleeding

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Alberta Heritage Foundation for Medical Research
Calgary Health Region
Information provided by (Responsible Party):
Dr. Robert Hilsden, University of Calgary
ClinicalTrials.gov Identifier:
NCT00203619
First received: September 13, 2005
Last updated: August 28, 2016
Last verified: August 2016
  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
Intervention Model: Parallel Assignment
Masking: None (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 Dr. Robert Hilsden, University of Calgary:

Primary Outcome Measures:
  • sf36 [ Time Frame: 48 weeks ]
  • giqli [ Time Frame: 48 weeks ]
  • eq50 [ Time Frame: 48 weeks ]
  • diagnostic yield [ Time Frame: 48 weeks ]

Secondary Outcome Measures:
  • transfusions [ Time Frame: 48 weeks ]

Enrollment: 40
Study Start Date: May 2005
Estimated Study Completion Date: September 2016
Primary Completion Date: September 2015 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Responsible Party: Dr. Robert Hilsden, Associate Professor, Department of Medicine & Research Director, Colon Cancer Screening Centre, University of Calgary
ClinicalTrials.gov Identifier: NCT00203619     History of Changes
Other Study ID Numbers: 1
Study First Received: September 13, 2005
Last Updated: August 28, 2016

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

ClinicalTrials.gov processed this record on August 22, 2017