SB3 Battery Life Observational Study

December 24, 2018 updated by: Robert Enns, University of British Columbia

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • St. Paul's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing small bowel capsule endoscopy

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion Rate (Rate at Which Small Bowel is Completely Examined)
Time Frame: 0.1 - 12 hours
rate at which small bowel is completely examined (capsule endoscopy enters cecum)
0.1 - 12 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Robert Enns, MD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

March 3, 2015

First Submitted That Met QC Criteria

March 6, 2015

First Posted (Estimate)

March 9, 2015

Study Record Updates

Last Update Posted (Actual)

April 2, 2019

Last Update Submitted That Met QC Criteria

December 24, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H14-03253

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Capsule Endoscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe