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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 January 2013 |
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Main ID: |
NCT01438645 |
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Date of registration:
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14/09/2011 |
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Primary sponsor: |
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Public title:
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ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy
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Scientific title:
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ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy for Improved Endoscopic Performance and Enhanced Patient Experience |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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250 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01438645 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
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Countries of recruitment
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Canada
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Contacts
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Name:
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Christopher W Teshima, MD FRCPC |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alberta |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Adult patient 18 years or older.
2. Able to read & write English.
3. Undergoing colonoscopy at University of Alberta Hospital for any indication.
Exclusion Criteria:
1. Colonoscopy performed without prior purgative bowel prep.
2. Patient with active, ongoing lower GI bleeding.
3. Colonoscopy performed to attempt colonic decompression in acute colonic
pseudo-obstruction (Ogilvie's syndrome).
4. Colonoscopy for which propofol sedation is required.
5. Inpatient colonoscopy performed by a trainee under staff supervision.
6. Patient with previous colonic surgery.
7. Patient with pacemaker or implantable cardioverter-defibrillator (ICD).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colonic Neoplasms
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Diarrhea
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Iron Deficiency Anemia
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Intervention(s)
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Device: Olympus ScopeGuide
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Primary Outcome(s)
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Sedation Score
[Time Frame: 1 day (immediate outcome assessment at time of endoscopy procedure)]
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Secondary Outcome(s)
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Ancillary maneuvers to facilitate procedure
[Time Frame: 1 day (immediate outcome assessment at time of endoscopy procedure)]
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Cecal intubation rate
[Time Frame: 1 day (immediate outcome assessment at time of endoscopy procedure)]
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Patient comfort
[Time Frame: 1 day (immediate outcome assessment after recovery from endoscopy procedure)]
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Time-to-cecum
[Time Frame: 1 day (immediate outcome assessment at time of endoscopy procedure)]
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Secondary ID(s)
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ScopeGuide 01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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