Capsule Endoscopy in Obscure GI Bleeding

Obscure Gastrointestinal Bleeding Clinical Trial

Official title:

An Economic Evaluation of Capsule Endoscopy for Obscure Gastrointestinal Bleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00203619
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: December 1, 2017
• Start date: May 2005
• Est. completion date: September 2016

Study information

• Verified date: December 2017
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Obscure Gastrointestinal Bleeding

Intervention

Device:
• Wireless capsule endoscopy
wire less capsule endoscopy

Other:
• standard care
standard diagnostic evaluation as decided by treating physician

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Alberta Heritage Foundation for Medical Research, Calgary Health Region

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sf36		48 weeks
Primary	giqli		48 weeks
Primary	eq50		48 weeks
Primary	diagnostic yield		48 weeks
Secondary	transfusions		48 weeks