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OpenTrials
Completed

NCT Number: NCT02382705

SB3 Battery Life 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.

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Key information

Conditions

Capsule Endoscopy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 2K5, Canada

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. Diagnostic Yield

    Time frame: 0.1 - 12 hours

    rate at which a pathological finding is identified on capsule endoscopy

  2. Gastric Transit Time

    Time frame: 0.1 - 12 hours

    time it takes for capsule camera to traverse the stomach

  3. Small Bowel Transit Time

    Time frame: 0.1 - 12 hours

    times it takes for capsule camera to traverse the entire small bowel.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Mar 9, 2015
Registry last updated
Apr 2, 2019

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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