SB3 Battery Life Observational Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Capsule Endoscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No