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Standard Colonoscopy Versus Colonoscopy With Endocuff Vision

Primary Purpose

Colorectal Polyp, Colorectal Adenoma, Colon Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endocuff Vision
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Polyp focused on measuring Colonoscopy screening, Colonscopy procedure

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Indiana University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Arm (Standard Colonscopy)

Endocuff Vision

Arm Description

Standard colonoscopy with no device attachments

Colonoscopy with Endocuff Vision attached to distal end of scope

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 29, 2017
Last Updated
July 25, 2019
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT03361917
Brief Title
Standard Colonoscopy Versus Colonoscopy With Endocuff Vision
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 11, 2017 (Actual)
Primary Completion Date
April 18, 2018 (Actual)
Study Completion Date
April 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Polyp, Colorectal Adenoma, Colon Cancer
Keywords
Colonoscopy screening, Colonscopy procedure

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm (Standard Colonscopy)
Arm Type
No Intervention
Arm Description
Standard colonoscopy with no device attachments
Arm Title
Endocuff Vision
Arm Type
Experimental
Arm Description
Colonoscopy with Endocuff Vision attached to distal end of scope
Intervention Type
Device
Intervention Name(s)
Endocuff Vision
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision)
Description
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.
Time Frame
During the withdrawal portion of the colonoscopy procedure
Secondary Outcome Measure Information:
Title
Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision)
Description
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.
Time Frame
During the insertion portion of the colonoscopy procedure
Title
Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision)
Description
Total procedure time is the time from the initial insertion through the complete withdrawal of the scope
Time Frame
During the colonoscopy procedure
Title
Detection Rates
Description
The percentage of participants with at least one of the indicated polyp types found during standard colonoscopy compared to colonoscopy with Endocuff Vision.
Time Frame
During the colonoscopy procedure
Title
Polyps Per Colonoscopy
Description
Number of adenomas or sessile serrated polyps found per colonoscopy of Standard colonoscopy compared to Colonoscopy with Endocuff Vision.
Time Frame
During the colonoscopy procedure
Title
Boston Bowel Preparation Score
Description
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.
Time Frame
During the withdrawal portion of the colonoscopy procedure after cleaning of the colon

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas K Rex, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
De-identified data can be shared in the future upon request.
Citations:
PubMed Identifier
28412271
Citation
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.
Results Reference
background
PubMed Identifier
30659990
Citation
Rex DK, Slaven JE, Garcia J, Lahr R, Searight M, Gross SA. Endocuff Vision Reduces Inspection Time Without Decreasing Lesion Detection: A Clinical Randomized Trial. Clin Gastroenterol Hepatol. 2020 Jan;18(1):158-162.e1. doi: 10.1016/j.cgh.2019.01.015. Epub 2019 Jan 17.
Results Reference
derived

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Standard Colonoscopy Versus Colonoscopy With Endocuff Vision

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