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Adenoma Detection Rate With a New Pediatric Colonoscope With a Short Turn Radius (Pentax Retroview) Compared With a Standard Pentax Pediatric Colonoscope

Primary Purpose

Colonoscopy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conventional Pediatric Colonoscope
Short-Turn Radius Colonoscope
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colonoscopy focused on measuring Colonoscopy, colon cancer screening

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability to provide Informed Consent
  • Age > 40
  • Surveillance Colonoscopy (History of Adenomas)

Exclusion Criteria:

  • Poor or Fair Bowel Prep
  • Difficult First Insertion
  • Familial Polyposis
  • Inflammatory Bowel Disease
  • Pregnancy
  • Active GI Bleeding
  • Prior colonic or rectal resection
  • Conserved Sattus
  • Colonoscopy less than 3 years ago
  • Screening Colonoscopy
  • Colonoscopy done to evaluate systems like abdominal pain, diarrhea, constipation, change in bowel habits

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Short-Turn Radius Colonoscope

    Conventional Pediatric Colonoscope

    Arm Description

    Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.

    Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.

    Outcomes

    Primary Outcome Measures

    Percentage of Patients With At Least One Adenoma
    Compare adenoma detection rate between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.

    Secondary Outcome Measures

    Overall Polyp Detection Rate
    Compare polyp detection rate (percent of patients with at least one polyp detected) between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.
    Mean Number of Adenomas Identified Per Patient With Polyps
    Compare average number of adenomas found per patient with polyps between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.

    Full Information

    First Posted
    January 11, 2019
    Last Updated
    June 27, 2019
    Sponsor
    Massachusetts General Hospital
    Collaborators
    Pentax Medical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03807089
    Brief Title
    Adenoma Detection Rate With a New Pediatric Colonoscope With a Short Turn Radius (Pentax Retroview) Compared With a Standard Pentax Pediatric Colonoscope
    Official Title
    Adenoma Detection Rate With a New Pediatric Colonoscope With a Short Turn Radius (Pentax Retroview) Compared With a Standard Pentax Pediatric Colonoscope
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2014 (Actual)
    Primary Completion Date
    May 11, 2017 (Actual)
    Study Completion Date
    May 11, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital
    Collaborators
    Pentax Medical

    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
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether the new colonoscope that provides both a traditional and a retrograde view (bending 180 degrees to look behind itself) of the colon can detect more polyps than a standard colonoscope that only provides a forward-facing view. The investigators wish to effectively demonstrate the utility of the new colonoscope (Pentax Retroview Colonoscope) as the objective of this study is to determine polyp and adenoma detection rates in human subjects undergoing colonoscopy for polyp surveillance.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colonoscopy
    Keywords
    Colonoscopy, colon cancer screening

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Short-Turn Radius Colonoscope
    Arm Type
    Experimental
    Arm Description
    Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.
    Arm Title
    Conventional Pediatric Colonoscope
    Arm Type
    Active Comparator
    Arm Description
    Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.
    Intervention Type
    Device
    Intervention Name(s)
    Conventional Pediatric Colonoscope
    Other Intervention Name(s)
    Pentax Model EG-2490K
    Intervention Type
    Device
    Intervention Name(s)
    Short-Turn Radius Colonoscope
    Other Intervention Name(s)
    Pentax Model EC-3490TLi
    Primary Outcome Measure Information:
    Title
    Percentage of Patients With At Least One Adenoma
    Description
    Compare adenoma detection rate between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.
    Time Frame
    1 hour
    Secondary Outcome Measure Information:
    Title
    Overall Polyp Detection Rate
    Description
    Compare polyp detection rate (percent of patients with at least one polyp detected) between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.
    Time Frame
    1 hour
    Title
    Mean Number of Adenomas Identified Per Patient With Polyps
    Description
    Compare average number of adenomas found per patient with polyps between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.
    Time Frame
    1 hour
    Other Pre-specified Outcome Measures:
    Title
    Size of Polyps Detected
    Description
    Polyp size was estimated prior to polypectomy by comparing the polyp with objects of known dimension (biopsy forceps, polypectomy snares).
    Time Frame
    1 hour
    Title
    Size of Adenomas Detected
    Time Frame
    1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ability to provide Informed Consent Age > 40 Surveillance Colonoscopy (History of Adenomas) Exclusion Criteria: Poor or Fair Bowel Prep Difficult First Insertion Familial Polyposis Inflammatory Bowel Disease Pregnancy Active GI Bleeding Prior colonic or rectal resection Conserved Sattus Colonoscopy less than 3 years ago Screening Colonoscopy Colonoscopy done to evaluate systems like abdominal pain, diarrhea, constipation, change in bowel habits
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Norman S Nishioka, MD
    Organizational Affiliation
    Massachusetts General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    8978338
    Citation
    Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8. doi: 10.1016/s0016-5085(97)70214-2.
    Results Reference
    background
    PubMed Identifier
    8978337
    Citation
    Rex DK, Rahmani EY, Haseman JH, Lemmel GT, Kaster S, Buckley JS. Relative sensitivity of colonoscopy and barium enema for detection of colorectal cancer in clinical practice. Gastroenterology. 1997 Jan;112(1):17-23. doi: 10.1016/s0016-5085(97)70213-0.
    Results Reference
    background
    PubMed Identifier
    19075198
    Citation
    Baxter NN, Goldwasser MA, Paszat LF, Saskin R, Urbach DR, Rabeneck L. Association of colonoscopy and death from colorectal cancer. Ann Intern Med. 2009 Jan 6;150(1):1-8. doi: 10.7326/0003-4819-150-1-200901060-00306. Epub 2008 Dec 15.
    Results Reference
    background
    PubMed Identifier
    20189513
    Citation
    DeMarco DC, Odstrcil E, Lara LF, Bass D, Herdman C, Kinney T, Gupta K, Wolf L, Dewar T, Deas TM, Mehta MK, Anwer MB, Pellish R, Hamilton JK, Polter D, Reddy KG, Hanan I. Impact of experience with a retrograde-viewing device on adenoma detection rates and withdrawal times during colonoscopy: the Third Eye Retroscope study group. Gastrointest Endosc. 2010 Mar;71(3):542-50. doi: 10.1016/j.gie.2009.12.021.
    Results Reference
    background
    PubMed Identifier
    15929759
    Citation
    Kessler WR, Rex DK. Impact of bending section length on insertion and retroflexion properties of pediatric and adult colonoscopes. Am J Gastroenterol. 2005 Jun;100(6):1290-5. doi: 10.1111/j.1572-0241.2005.41454.x.
    Results Reference
    background
    PubMed Identifier
    20018280
    Citation
    Waye JD, Heigh RI, Fleischer DE, Leighton JA, Gurudu S, Aldrich LB, Li J, Ramrakhiani S, Edmundowicz SA, Early DS, Jonnalagadda S, Bresalier RS, Kessler WR, Rex DK. A retrograde-viewing device improves detection of adenomas in the colon: a prospective efficacy evaluation (with videos). Gastrointest Endosc. 2010 Mar;71(3):551-6. doi: 10.1016/j.gie.2009.09.043. Epub 2009 Dec 16.
    Results Reference
    background

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    Adenoma Detection Rate With a New Pediatric Colonoscope With a Short Turn Radius (Pentax Retroview) Compared With a Standard Pentax Pediatric Colonoscope

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