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Trial record 1 of 1 for:    NCT00694954
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Capsule Endoscopy vs Standard of Care for Obscure Intestinal Bleeding

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by University of Calgary.
Recruitment status was:  Recruiting
Alberta Heritage Foundation for Medical Research
Calgary Health Region
Information provided by (Responsible Party):
Dr. Robert Hilsden, University of Calgary Identifier:
First received: December 14, 2007
Last updated: December 16, 2011
Last verified: December 2011
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.

Condition Intervention Phase
Iron Deficiency Anemia
Device: Diagnostic Test - Given Imaging Pillcam
Other: Diagnostics
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Randomized Controlled Trial of Capsule Endoscopy vs Standard Care in Patients With Iron Deficiency Anemia With Suspected Obscure / Occult Gastrointestinal Bleeding

Resource links provided by NLM:

Further study details as provided by University of Calgary:

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

Secondary Outcome Measures:
  • number of blood transfusions [ Time Frame: 48 weeks ]
  • number of hospitalizations for GI bleeding/anemia [ Time Frame: 48 weeks ]
  • number of GI-related procedures and investigations [ Time Frame: 48 ]
  • procedure-related complications [ Time Frame: 48 ]
  • quality of life [ Time Frame: 48 ]
    measured by 1) SF36 - 8 domains + PCS/MCS, 2) GI Quality of Life Index (GIQLI), 3) EQ-5D - index + visual analogue scale

  • health care costs [ Time Frame: 2 years ]

Estimated Enrollment: 160
Study Start Date: February 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Wireless capsule endoscopy
Device: 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)

Other Names:
  • Capsule endoscopy
  • Given Imaging Pillcam
  • Pill camera
Active Comparator: 2
Standard Care
Other: Diagnostics
Any other diagnostic tests (if not already performed) that the referring or attending physician deems necessary aside from Wireless Capsule Endoscopy.

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00694954

Contact: Catherine Dube, MD PhD 403-592-5020

Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4N1
Contact: Catherine Dube, MD PhD    403-592-5020   
Contact: Robert Hilsden, MD PhD    403-592-5100   
Principal Investigator: Catherine J Dube, MD PhD, MSc         
Sub-Investigator: Steven Heitman, MD, PhD         
Sub-Investigator: Rostom Alaa, MD, PhD         
Sub-Investigator: Hilsden Robert, MD, PhD         
Sub-Investigator: Braden Manns, MD, PhD         
Sub-Investigator: Fatin Adams, Md, PhD         
Sub-Investigator: Noel Hershfield, MD, PhD         
Sub-Investigator: Jonathan Love, MD, PhD         
Sub-Investigator: Michael Ma, MD, PhD         
Sponsors and Collaborators
University of Calgary
Alberta Heritage Foundation for Medical Research
Calgary Health Region
Principal Investigator: Catherine J. Dube, MD PhD University of Calgary
  More Information

Responsible Party: Dr. Robert Hilsden, Associate Professor, University of Calgary Identifier: NCT00694954     History of Changes
Other Study ID Numbers: E20270
Internal tracking #1763
Study First Received: December 14, 2007
Last Updated: December 16, 2011

Keywords provided by University of Calgary:
Iron deficiency anemia
Wireless capsule endoscopy
Obscure-occult gastrointestinal bleeding

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Deficiency Diseases
Gastrointestinal Hemorrhage
Hematologic Diseases
Pathologic Processes
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Gastrointestinal Diseases
Digestive System Diseases processed this record on April 26, 2017