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Completed

NCT Number: NCT00203619

Capsule Endoscopy in Obscure GI Bleeding

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

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Key information

Conditions

Obscure Gastrointestinal Bleeding

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, T2N4N1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wireless Capsule Endoscopy

Device

wire less capsule endoscopy

Standard care

Other

standard diagnostic evaluation as decided by treating physician

Primary outcomes

  1. sf36

    Time frame: 48 weeks

  2. giqli

    Time frame: 48 weeks

  3. eq50

    Time frame: 48 weeks

  4. diagnostic yield

    Time frame: 48 weeks

Secondary outcomes

  1. transfusions

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Alberta Heritage Foundation for Medical Research
  • Calgary Health Region

Registry information

Official study title

An Economic Evaluation of Capsule Endoscopy for Obscure Gastrointestinal Bleeding

Important dates

Study start
2005
Primary completion
2015
Study completion
2016
First posted
Sep 20, 2005
Registry last updated
Dec 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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