Standard Colonoscopy Versus Colonoscopy With Endocuff Vision
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03361917|
Recruitment Status : Completed
First Posted : December 5, 2017
Results First Posted : May 22, 2019
Last Update Posted : August 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Polyp Colorectal Adenoma Colon Cancer||Device: Endocuff Vision||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Controlled Trial of High-Definition White-light Colonoscopy Versus High-Definition White-light Colonoscopy With Endocuff Vision for Endpoints of Procedural Times|
|Actual Study Start Date :||December 11, 2017|
|Actual Primary Completion Date :||April 18, 2018|
|Actual Study Completion Date :||April 18, 2018|
No Intervention: Control Arm (Standard Colonscopy)
Standard colonoscopy with no device attachments
Experimental: Endocuff Vision
Colonoscopy with Endocuff Vision attached to distal end of scope
Device: Endocuff Vision
Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.
- Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision) [ Time Frame: During the withdrawal portion of the colonoscopy procedure ]Inspection time is time spent actually examining the colon. This was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. It was measured during colonoscopy by a study assistant using a stopwatch.
- Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision) [ Time Frame: During the insertion portion of the colonoscopy procedure ]Insertion time is the time it takes from the colonoscope first being inserted to when the furthest section of the colon (which is called the cecum) is reached.
- Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision) [ Time Frame: During the colonoscopy procedure ]Total procedure time is the time from the initial insertion through the complete withdrawal of the scope
- Detection Rates [ Time Frame: During the colonoscopy procedure ]The percentage of participants with at least one of the indicated polyp types found during standard colonoscopy compared to colonoscopy with Endocuff Vision.
- Polyps Per Colonoscopy [ Time Frame: During the colonoscopy procedure ]Number of adenomas or sessile serrated polyps found per colonoscopy of Standard colonoscopy compared to Colonoscopy with Endocuff Vision.
- Boston Bowel Preparation Score [ Time Frame: During the withdrawal portion of the colonoscopy procedure after cleaning of the colon ]
Boston Bowel Preparation Score for patients receiving standard colonoscopy compared to colonoscopy with endocuff vision.
The total score for the Boston Bowel Preparation Scale ranges from 0 to 9, with higher score indicating a better bowel preparation quality.
The quality of the bowel preparation is assessed by the attending gastroenterologist.
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): NCT03361917
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Douglas K Rex, MD||Indiana University|