Overview

This trial is active, not recruiting.

Condition obscure gastrointestinal bleeding
Treatments wireless capsule endoscopy, standard care
Phase phase 4
Sponsor University of Calgary
Collaborator Alberta Heritage Foundation for Medical Research
Start date May 2005
End date September 2015
Trial size 40 participants
Trial identifier NCT00203619, 1

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Wireless capsule endoscopy
wireless capsule endoscopy
wire less capsule endoscopy
(Active Comparator)
Standard care
standard care
standard diagnostic evaluation as decided by treating physician

Primary Outcomes

Measure
sf36
time frame: 48 weeks
giqli
time frame: 48 weeks
eq50
time frame: 48 weeks
diagnostic yield
time frame: 48 weeks

Secondary Outcomes

Measure
transfusions
time frame: 48 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title An Economic Evaluation of Capsule Endoscopy for Obscure Gastrointestinal Bleeding
Principal investigator Robert J Hilsden, MD PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Calgary.