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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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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Yield | rate at which a pathological finding is identified on capsule endoscopy | 0.1 - 12 hours |
| Gastric Transit Time | time it takes for capsule camera to traverse the stomach |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing small bowel capsule endoscopy
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| Name | Affiliation | Role |
|---|---|---|
| Robert Enns, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 2K5 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | PillCam SB3EX | All participants in the study used the PillCam SB3EX for their capsule endoscopy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | PillCam SB3EX | All participants in the study used the PillCam SB3EX for their capsule endoscopy |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Completion Rate (Rate at Which Small Bowel is Completely Examined) | rate at which small bowel is completely examined (capsule endoscopy enters cecum) | Posted | Count of Participants | Participants | 0.1 - 12 hours |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PillCam SB3EX | Patients who were eligible to participate in the study were recruited and enrolled. Enrolled participants were given instructions for capsule endoscopy as per standard of practice at our institution. External sensors and data recorder for use with the PillCam capsule were placed. Patients swallowed the capsule. All capsule endoscopy were allowed to run/record until the recording terminates due to battery outage (usually after 12 h) or passage of CE out of the gastrointestinal tract, as indicated by cessation of flashing light on the recorder. External sensors and data recorder were removed at the end of the recording and patients returned the equipment to the institution the next day. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Enns | University of British Columbia | 604 688 6332 | cgalorport@gmail.com |
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| 0.1 - 12 hours |
| Small Bowel Transit Time | times it takes for capsule camera to traverse the entire small bowel. | 0.1 - 12 hours |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Diagnostic Yield | rate at which a pathological finding is identified on capsule endoscopy | Posted | Count of Participants | Participants | 0.1 - 12 hours |
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| Secondary | Gastric Transit Time | time it takes for capsule camera to traverse the stomach | Posted | Mean | Standard Deviation | minutes | 0.1 - 12 hours |
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| Secondary | Small Bowel Transit Time | times it takes for capsule camera to traverse the entire small bowel. | Posted | Mean | Standard Deviation | minutes | 0.1 - 12 hours |
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| 0 |
| 57 |
| 0 |
| 57 |
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