Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy

Indiana University634 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

634

Conditions

Colorectal Adenoma Colorectal Polyp Colorectal Cancer

Interventions

Endocuff Vision deviceDEVICE

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 deviceDEVICE

Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure.

Eligibility

Sex: ALLMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Indiana University

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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.

Time frame: During colonoscopy procedure

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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