SB3 Battery Life Observational Study

Completed

• Conditions: Capsule Endoscopy

• Registration Number: NCT02382705
• Lead Sponsor: University of British Columbia

Brief Summary

Capsule endoscopy (CE) is a non-invasive means of visualizing the small bowel. Common indications for CE include obscure gastrointestinal (GI) bleeding, inflammatory bowel disease like crohn's disease or ulcerative colitis, celiac disease, and polyposis syndrome.

While CE has high diagnostic value for small bowel lesions, a significant limitation of this technology is the finite battery life which results in incomplete examination of the small bowel approximately 16.5% of the time. Numerous attempts of using pharmacological (e.g. prokinetics, purgatives) as well as non-pharmacological measures (e.g. real-time viewer, chewing gum) to improve completion rates, defined by entry of CE into the cecum, led to mixed results. Currently routine use of prokinetics (agents that speeds up gut motility) is not recommended.

This study aims to determine whether longer battery of the newer generation capsule endoscopy system improves study completion rate and diagnostic yield.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-03
• Study First Submitted QC: 2015-03-06
• Study First Posted: 2015-03-09
• Primary Completion: 2016-12
• Study Completion: 2017-02
• Status Verified: 2018-12
• Results First Submitted: 2018-12-24
• Results First Submitted QC: 2018-12-24
• Last Update Submitted: 2018-12-24
• Results First Posted: 2019-04-02
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Male or female age 19 or greater who are referred for small bowel capsule endoscopy
• Willing and able to provide written informed consent

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Exclusion Criteria

• Unwillingness or inability to swallow pill
• Known or suspected obstruction or bowel stricture
• Endoscopic placement of capsule camera
• Concomitant enrollment in a prospective study in the treatment arm receiving prokinetics for the purpose of enhancing bowel motility. (i.e. control arm not receiving any motility-enhancing agent can be included)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Completion Rate (Rate at Which Small Bowel is Completely Examined)	0.1 - 12 hours	rate at which small bowel is completely examined (capsule endoscopy enters cecum)

Secondary Outcome Measures

Name	Time	Method
Diagnostic Yield	0.1 - 12 hours	rate at which a pathological finding is identified on capsule endoscopy
Small Bowel Transit Time	0.1 - 12 hours	times it takes for capsule camera to traverse the entire small bowel.
Gastric Transit Time	0.1 - 12 hours	time it takes for capsule camera to traverse the stomach

Trial Locations

Locations (1)

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada