SB3 Battery Life Observational Study
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6Z 2K5
- St. Paul's Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Completion Rate (Rate at Which Small Bowel is Completely Examined)
Tidsramme: 0.1 - 12 hours
|
rate at which small bowel is completely examined (capsule endoscopy enters cecum)
|
0.1 - 12 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Diagnostic Yield
Tidsramme: 0.1 - 12 hours
|
rate at which a pathological finding is identified on capsule endoscopy
|
0.1 - 12 hours
|
|
Gastric Transit Time
Tidsramme: 0.1 - 12 hours
|
time it takes for capsule camera to traverse the stomach
|
0.1 - 12 hours
|
|
Small Bowel Transit Time
Tidsramme: 0.1 - 12 hours
|
times it takes for capsule camera to traverse the entire small bowel.
|
0.1 - 12 hours
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Robert Enns, MD, University of British Columbia
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- H14-03253
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