Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy

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

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colorectal Adenoma; Colorectal Polyp
• Intervention / Treatment: Device: Endocuff Vision device; Device: AmplifEYE device

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 634
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Indiana University

Publications and helpful links

General Publications

• 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.
• Rex DK, Sagi SV, Kessler WR, Rogers NA, Fischer M, Bohm ME, Dewitt JM, Lahr RE, Searight MP, Sullivan AW, McWhinney CD, Garcia JR, Broadley HM, Vemulapalli KC. A comparison of 2 distal attachment mucosal exposure devices: a noninferiority randomized controlled trial. Gastrointest Endosc. 2019 Nov;90(5):835-840.e1. doi: 10.1016/j.gie.2019.06.046. Epub 2019 Jul 15.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2018
• Primary Completion (Actual): December 18, 2018
• Study Completion (Actual): December 18, 2018

Study Registration Dates

• First Submitted: June 6, 2018
• First Submitted That Met QC Criteria: June 15, 2018
• First Posted (Actual): June 18, 2018

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: September 20, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Colonoscopy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Adenoma; Polyps
• Other Study ID Numbers: 1802193017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified data can be shared in the future upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes