Capsule EndoscopyNCT02382705
SB3 Battery Life Observational Study
An observational study of Capsule Endoscopy, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Capsule Endoscopy
- How many people
- 57 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Feb 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing small bowel capsule endoscopy
Who may be able to join
- Male or female age 19 or greater who are referred for small bowel capsule endoscopy
- Willing and able to provide written informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Capsule Endoscopy
- Keywords
- capsule endoscopy, battery life, completion rate, diagnostic yield
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion Rate (Rate at Which Small Bowel is Completely Examined)
rate at which small bowel is completely examined (capsule endoscopy enters cecum)
Measured: 0.1 - 12 hours
Secondary outcomes (3)
Diagnostic Yield
rate at which a pathological finding is identified on capsule endoscopy
Measured: 0.1 - 12 hours
Gastric Transit Time
time it takes for capsule camera to traverse the stomach
Measured: 0.1 - 12 hours
Small Bowel Transit Time
times it takes for capsule camera to traverse the entire small bowel.
Measured: 0.1 - 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Capsule EndoscopyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Enns, University of British Columbia
- Investigators
- Robert Enns, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382705
- Sponsor's protocol ID
- H14-03253
- Status last verified
- Dec 2018
- First submitted
- 3 Mar 2015
- Last updated
- 2 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Longer Battery Life on Small Bowel Capsule Endoscopy: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02382705
- Acronym / sponsor ID
- H14-03253
- Conditions
- Capsule Endoscopy
- Keywords
- capsule endoscopy, battery life, completion rate, diagnostic yield
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Posted 2 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing small bowel capsule endoscopy
Key inclusion criteria (2 listed)
- Male or female age 19 or greater who are referred for small bowel capsule endoscopy
- Willing and able to provide written informed consent
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
3 secondary outcomes
Diagnostic Yield
Time frame: 0.1 - 12 hours
Gastric Transit Time
Time frame: 0.1 - 12 hours
Small Bowel Transit Time
Time frame: 0.1 - 12 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Accurately Profiling the Changes and Functions of Key Microflora in the Whole Intestinal Microenvironment Based on the Visual Sampling Capsule Endoscopy in Patients With Inflammatory Bowel Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Enns, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Capsule Endoscopy, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion Rate (Rate at Which Small Bowel is Completely Examined) (time frame: 0.1 - 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.