Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT01370928|
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : April 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Adenomas||Device: Olympus PCF-Y0014-L Device: Standard colonoscope||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||190 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||August 2011|
Experimental: Prototype colonoscope
The new colonoscope to be tested
Device: Olympus PCF-Y0014-L
Screening colonoscopy with a prototype colonoscope
Other Name: Olympus PCF-Y0014-L colonoscope
Active Comparator: Standard colonoscope
The standard colonoscope used world-wide today.
Device: Standard colonoscope
Other Name: Olympus series 160 colonoscope
- Patients´ evaluation of pain and discomfort [ Time Frame: 24 hours ]Analysis of validated feed-back questionnaires to be filled in on the day after the proceudre by the trial participants.
- Time used to reach the caecum [ Time Frame: 1 hour ]The time used to reach the caecum will be recorded with a stop watch during the procedure.
- Need for sedation/analgesics during the colonoscopy procedure [ Time Frame: 1 hour ]If sedation/analgesics is administered during the colonoscopy procedure, the name of the agent, dose and route of administration will be recorded immediately.
- Need to change to a different colonoscope to complete the procedure [ Time Frame: 10 minutes ]If the colonoscopist decides to change to a different colonoscope during the procedure, the reason is recorded immediately after the procedure. The number of procedures where there is a change of colonoscope will be recorded.
- Caecum intubation rate [ Time Frame: 30 minutes ]The colonic segment reached during each colonoscopy is recorded immediately following the procedure. Caecal intubation rate describes the number of complete colonoscopies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370928
|Sørlandet Sykehus HF|
|Kristiansand, Norway, 4604|
|Study Chair:||Michael Bretthauer, MD, Ph.d.||Oslo University Hospital|