N/A
Completed N=57
SB3 Battery Life Observational Study
Capsule Endoscopy
Source: ClinicalTrials.gov NCT02382705 ↗
Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Completion Rate (Rate at Which Small Bowel is Completely Examined) — 57 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Completion Rate (Rate at Which Small Bowel is Completely Examined) |
57 | — |
| SECONDARY Diagnostic Yield |
20 | — |
| SECONDARY Gastric Transit Time |
37.6 | — |
| SECONDARY Small Bowel Transit Time |
232.1 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02382705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.