Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy
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|ClinicalTrials.gov Identifier: NCT03560128|
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : July 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Adenoma Colorectal Polyp Colorectal Cancer||Device: Endocuff Vision device Device: AmplifEYE device||Not Applicable|
This will be a prospective, randomized controlled study. Subjects referred for a screening, surveillance, or diagnostic colonoscopy will be prospectively enrolled. This study aims to compare the number of adenomas detected per colonoscopy (APC) between an Endocuff colonoscopy and an AmplifEYE colonoscopy.
It is estimated that the Endocuff Vision will result in an APC of 2.3. The investigators consider that a clinically acceptable ADR for the Medivators device would be within 20% of this value or 1.5.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||588 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Endocuff Vision to Medivators AmplifEYE for Detection of Precancerous Colorectal Polyps.|
|Actual Study Start Date :||April 12, 2018|
|Estimated Primary Completion Date :||September 30, 2018|
|Estimated Study Completion Date :||September 30, 2018|
Experimental: Endocuff Vision Arm
Colonoscopy with Endocuff Vision device attached to the distal end of the scope.
Device: Endocuff Vision device
Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure.
Experimental: AmplifEYE Arm
Colonoscopy with AmplifEYE device attached to the distal end of the scope.
Device: AmplifEYE device
Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure.
- Number of Adenomas Detected per Colonoscopy (APC). [ Time Frame: 1 day ]Comparison of the number of adenomas detected per colonoscopy between the Endocuff Colonoscopy and the AmplifEYE colonoscopy.
- Detection Rates (ADR and PDR) [ Time Frame: 1 day ]Comparison of the number of adenomas (ADR) and number of polyps (PDR) detected per subject between the AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.
- Complications encountered during procedure [ Time Frame: 1 day ]Comparison of amount of mucosal trauma, perforation, or gastrointestinal bleeding between patients that have AmplifEYE colonoscopy compared to patients that have Endocuff Vision colonoscopy.
- Passage of device through Sigmoid Colon [ Time Frame: 1 day ]Comparison of how easily device is passed through the sigmoid colon between colonoscopies with the AmplifEYE device and colonoscopies with the Endocuff Vision device.
- Polyps per Colonoscopy (PPC) [ Time Frame: 1 day ]Comparison of the number of polyps detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.
- Time Comparison for Each Method [ Time Frame: 1 day ]Comparison of the time required to reach the cecum, overall withdrawal time, inspection time, and total procedure time between the AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.
- Cecal Intubation Rate [ Time Frame: 1 day ]Comparison of cecal intubation rate between AmplifEYE colonoscopy and Endocuf Vision colonoscopy.
- Detection of Serrated and Flat lesions [ Time Frame: 1 day ]Comparison of the serrated lesions and the flat lesions detected between the Endocuff Vision colonoscopy and the AmplifEYE colonoscopy.
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): NCT03560128
|Contact: Jonathan Garciafirstname.lastname@example.org|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|Contact: Jonathan Garcia 317-948-0117 email@example.com|
|Contact: Rachel Lahr 317-948-0724 firstname.lastname@example.org|
|Principal Investigator: Douglas K Rex, MD|