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Completed

NCT Number: NCT03361917

Standard Colonoscopy Versus Colonoscopy With Endocuff Vision

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

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Key information

Conditions

Colorectal Polyp Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Adenoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endocuff vision

Device

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 5, 2017
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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