Neoplasms

All Conditions

Symptoms and General Pathology

Adenoma

Polyps

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Standard colonoscopy with no device attachments

Colonoscopy with Endocuff Vision attached to distal end of scope

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.

Endocuff Vision

Douglas K Rex, MD

This study seeks to compare colonoscopy results between a standard method and one using a distal scope attachment (Endocuff Vision).

For this study, subjects will be randomized into one of two groups (those who receive a standard colonoscopy and those who receive a colonoscopy with an Endocuff Vision attachment). Results will then be compared between the two; these include insertion time (time it takes to reach the cecum of the large intestine), inspection time (time spent examining the large intestine), the total time per each polypectomy (removal of polyps in the colon), and the total procedure time of the colonoscopy.

Standard Colonoscopy Versus Colonoscopy With Endocuff Vision

Prospective Randomized Controlled Trial of High-Definition White-light Colonoscopy Versus High-Definition White-light Colonoscopy With Endocuff Vision for Endpoints of Procedural Times

De-identified data can be shared in the future upon request.

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 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 is the time from the initial insertion through the complete withdrawal of the scope

The percentage of participants with at least one of the indicated polyp types found during standard colonoscopy compared to colonoscopy with Endocuff Vision.

Number of adenomas or sessile serrated polyps found per colonoscopy of Standard colonoscopy compared to Colonoscopy with Endocuff Vision.

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.

Indiana University

Distinguished Professor

Control Arm (Standard Colonscopy)

Colonoscopy with Endocuff Vision attached to distal end of scope

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.

Total

Age, Continuous

Sex: Female, Male

White

Other

Race/Ethnicity, Customized

United States

Region of Enrollment

Gastroenterology fellows assisting in insertion

Screening

Surveillance

Procedure Indication

Examiners were not blinded to the device used. Only 2 examiners with experience with the device participated in the study so generalizability of the results is unknown.

Data was not collected on other potential confounders like smoking or BMI.

Spots Global Cancer Trial Database for colonscopy procedure