Standard Colonoscopy Versus Colonoscopy With Endocuff Vision

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03361917
• Other study ID #: 1709336500
• Status: Completed
• Phase: N/A
• Start date: December 11, 2017
• Est. completion date: April 18, 2018

Study information

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

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 18, 2018
• Est. primary completion date: April 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Subject referred for a screening or surveillance colonoscopy

• Subject is aged 40 years or older

• Subject has the ability to provide informed consent

Exclusion Criteria:

• Prior history of colon cancer

• History of inflammatory bowel disease

• Prior surgical resection of any part of the colon

• Use of antiplatelet agents or anticoagulants that precludes the removal of polyps during the procedure

• History of polyposis syndrome or HNPCC

• Family history of colon cancer in a first-degree relative < 60 years or two first degree relatives with colorectal cancer

• Inability to provide informed consent

Related Conditions & MeSH terms

• Adenoma
• Colon Cancer
• Colorectal Adenoma
• Colorectal Polyp

Intervention

Device:
• 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.

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)

Tsiamoulos ZP, Misra R, Rameshshanker R, Elliott TR, Beintaris I, Thomas-Gibson S, Haycock A, Suzuki N, Rees C, Saunders BP. Impact of a new distal attachment on colonoscopy performance in an academic screening center. Gastrointest Endosc. 2018 Jan;87(1):280-287. doi: 10.1016/j.gie.2017.04.001. Epub 2017 Apr 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision)	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.	During the withdrawal portion of the colonoscopy procedure
Secondary	Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision)	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.	During the insertion portion of the colonoscopy procedure
Secondary	Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision)	Total procedure time is the time from the initial insertion through the complete withdrawal of the scope	During the colonoscopy procedure
Secondary	Detection Rates	The percentage of participants with at least one of the indicated polyp types found during standard colonoscopy compared to colonoscopy with Endocuff Vision.	During the colonoscopy procedure
Secondary	Polyps Per Colonoscopy	Number of adenomas or sessile serrated polyps found per colonoscopy of Standard colonoscopy compared to Colonoscopy with Endocuff Vision.	During the colonoscopy procedure
Secondary	Boston Bowel Preparation Score	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.	During the withdrawal portion of the colonoscopy procedure after cleaning of the colon