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Standard Colonoscopy Versus Colonoscopy With Endocuff Vision

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03361917
Recruitment Status : Completed
First Posted : December 5, 2017
Results First Posted : May 22, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Douglas K. Rex, Indiana University

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

Condition or disease Intervention/treatment Phase
Colorectal Polyp Colorectal Adenoma Colon Cancer Device: Endocuff Vision Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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
Actual Study Start Date : December 11, 2017
Actual Primary Completion Date : April 18, 2018
Actual Study Completion Date : April 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control Arm (Standard Colonscopy)
Standard colonoscopy with no device attachments
Experimental: Endocuff Vision
Colonoscopy with Endocuff Vision attached to distal end of scope
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision) [ Time Frame: During the withdrawal portion of the colonoscopy procedure ]
    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 :
  1. Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision) [ Time Frame: During the insertion portion of the colonoscopy procedure ]
    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.

  2. Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision) [ Time Frame: During the colonoscopy procedure ]
    Total procedure time is the time from the initial insertion through the complete withdrawal of the scope

  3. Detection Rates [ Time Frame: During the colonoscopy procedure ]
    The percentage of participants with at least one of the indicated polyp types found during standard colonoscopy compared to colonoscopy with Endocuff Vision.

  4. Polyps Per Colonoscopy [ Time Frame: During the colonoscopy procedure ]
    Number of adenomas or sessile serrated polyps found per colonoscopy of Standard colonoscopy compared to Colonoscopy with Endocuff Vision.

  5. Boston Bowel Preparation Score [ Time Frame: During the withdrawal portion of the colonoscopy procedure after cleaning of the colon ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361917


Locations
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United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Douglas K Rex, MD Indiana University
  Study Documents (Full-Text)

Documents provided by Douglas K. Rex, Indiana University:
Study Protocol and Statistical Analysis Plan  [PDF] May 10, 2018

More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Douglas K. Rex, Distinguished Professor, Indiana University
ClinicalTrials.gov Identifier: NCT03361917    
Obsolete Identifiers: NCT03398447
Other Study ID Numbers: 1709336500
First Posted: December 5, 2017    Key Record Dates
Results First Posted: May 22, 2019
Last Update Posted: August 6, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-identified data can be shared in the future upon request.

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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
Keywords provided by Douglas K. Rex, Indiana University:
Colonoscopy screening
Colonscopy procedure
Additional relevant MeSH terms:
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Adenoma
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type