SB3 Battery Life Observational Study

NCT02382705 | Completed Results

• 1 other identifier: H14-03253
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Capsule Endoscopy

Keywords

capsule endoscopy; battery life; completion rate; diagnostic yield

Outcome Measures

Primary Outcomes (1)

• Completion Rate (Rate at Which Small Bowel is Completely Examined)

  rate at which small bowel is completely examined (capsule endoscopy enters cecum)

  0.1 - 12 hours

Secondary Outcomes (3)

• Diagnostic Yield

  0.1 - 12 hours

• Gastric Transit Time

  0.1 - 12 hours

• Small Bowel Transit Time

  0.1 - 12 hours

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing small bowel capsule endoscopy

You may qualify if:

• Male or female age 19 or greater who are referred for small bowel capsule endoscopy
• Willing and able to provide written informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Results Point of Contact

• Title: Dr. Robert Enns
• Organization: University of British Columbia

cgalorport@gmail.com

604 688 6332

Study Officials

• Robert Enns, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 9, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: April 2, 2019
• Results First Posted: April 2, 2019

Record last verified: 2018-12

Locations

CA (1)