SB3 Battery Life Observational Study

Capsule Endoscopy Clinical Trial

Official title:

Clinical Impact of Longer Battery Life on Small Bowel Capsule Endoscopy: a Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382705
• Other study ID #: H14-03253
• Status: Completed
• Start date: February 2015
• Est. completion date: February 2017

Study information

• Verified date: December 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

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)

Related Conditions & MeSH terms

• Capsule Endoscopy

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion Rate (Rate at Which Small Bowel is Completely Examined)	rate at which small bowel is completely examined (capsule endoscopy enters cecum)	0.1 - 12 hours
Secondary	Diagnostic Yield	rate at which a pathological finding is identified on capsule endoscopy	0.1 - 12 hours
Secondary	Gastric Transit Time	time it takes for capsule camera to traverse the stomach	0.1 - 12 hours
Secondary	Small Bowel Transit Time	times it takes for capsule camera to traverse the entire small bowel.	0.1 - 12 hours