Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy

Colorectal Cancer Clinical Trial

Official title:

Comparison of Endocuff Vision to Medivators AmplifEYE for Detection of Precancerous Colorectal Polyps.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03560128
• Other study ID #: 1802193017
• Status: Completed
• Phase: N/A
• Start date: April 12, 2018
• Est. completion date: December 18, 2018

Study information

• Verified date: September 2019
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to compare the results between colonoscopies with two different attachments on the distal end of the colonoscope.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 634
• Est. completion date: December 18, 2018
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 40 years of age or older

• Undergoing colonoscopy for screening, surveillance, or diagnostic purposes

• Able to provide written informed consent

Exclusion Criteria:

• Active Inflammatory Bowel Disease

• Prior resection of the colon

• Referred for resection of a polyp identified by another physician

• Referred for a previous incomplete colonoscopy

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma
• Colorectal Cancer
• Colorectal Polyp
• Polyps

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rex DK, Repici A, Gross SA, Hassan C, Ponugoti PL, Garcia JR, Broadley HM, Thygesen JC, Sullivan AW, Tippins WW, Main SA, Eckert GJ, Vemulapalli KC. High-definition colonoscopy versus Endocuff versus EndoRings versus full-spectrum endoscopy for adenoma detection at colonoscopy: a multicenter randomized trial. Gastrointest Endosc. 2018 Aug;88(2):335-344.e2. doi: 10.1016/j.gie.2018.02.043. Epub 2018 Mar 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adenomas Detected Per Colonoscopy (APC).	Comparison of the number of adenomas detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.	During colonoscopy procedure
Secondary	Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR))	Comparison of the number of participants with at least one adenoma detected (ADR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.; Comparison of the number of participants with at least one polyp detected (PDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.	During colonoscopy procedure
Secondary	Complications Encountered During Procedure	Comparison of amount of mucosal trauma (such as scratches), perforation (making a hole in the colon wall), or gastrointestinal bleeding between patients that have AmplifEYE colonoscopy compared to patients that have Endocuff Vision colonoscopy.	During Colonoscopy procedure
Secondary	Passage of Device Through Sigmoid Colon	Comparison of the number of times the device had to be removed to pass the sigmoid colon between colonoscopies with the AmplifEYE device and colonoscopies with the Endocuff Vision device.	during insertion portion of colonoscopy
Secondary	Polyps Per Colonoscopy (PPC)	Comparison of the number of polyps detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.	During colonoscopy procedure
Secondary	Time Comparison for Each Method	Comparison of the insertion time, overall withdrawal time, inspection time, and total procedure time between the AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.; Insertion time: time it takes from the colonoscope first being inserted to when the cecum is reached Withdrawal time: time calculated from when withdrawing is started in the cecum until the colonoscope is removed. This includes time spent washing, suctioning, inspecting the colon, and removing polyps.; Inspection time: time spent actually examining the colon and does not include time spent for washing the colon, suctioning, and removing polyps.; Total procedure time: time from the initial insertion of the colonoscope through the complete withdrawal of the colonoscope.	During colonoscopy procedure
Secondary	Cecal Intubation Rate	Comparison of the number of procedures where the colonoscope was able to reach the cecum between AmplifEYE colonoscopy and Endocuff Vision colonoscopy.	During Colonoscopy procedure
Secondary	Detection of Serrated Lesions	Comparison of the number of participants with at least one Sessile Serrated Polyp detected (SSPDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.; Comparison of the number of participants with at least one flat polyp detected between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.	During colonoscopy procedure