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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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ClinicalTrials.gov Identifier: NCT03807089
Recruitment Status : Completed
First Posted : January 16, 2019
Results First Posted : July 16, 2019
Last Update Posted : July 16, 2019
Sponsor:
Collaborator:
Pentax Medical
Information provided by (Responsible Party):
Norman Nishioka, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Colonoscopy Device: Conventional Pediatric Colonoscope Device: Short-Turn Radius Colonoscope Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 283 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adenoma Detection Rate With a New Pediatric Colonoscope With a Short Turn Radius (Pentax Retroview) Compared With a Standard Pentax Pediatric Colonoscope
Actual Study Start Date : July 1, 2014
Actual Primary Completion Date : May 11, 2017
Actual Study Completion Date : May 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: Short-Turn Radius Colonoscope
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 The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.
Device: Short-Turn Radius Colonoscope
Other Name: Pentax Model EC-3490TLi

Active Comparator: Conventional Pediatric Colonoscope
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.
Device: Conventional Pediatric Colonoscope
Other Name: Pentax Model EG-2490K




Primary Outcome Measures :
  1. Percentage of Patients With At Least One Adenoma [ Time Frame: 1 hour ]
    Compare adenoma detection rate between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.


Secondary Outcome Measures :
  1. Overall Polyp Detection Rate [ Time Frame: 1 hour ]
    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.

  2. Mean Number of Adenomas Identified Per Patient With Polyps [ Time Frame: 1 hour ]
    Compare average number of adenomas found per patient with polyps between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.


Other Outcome Measures:
  1. Size of Polyps Detected [ Time Frame: 1 hour ]
    Polyp size was estimated prior to polypectomy by comparing the polyp with objects of known dimension (biopsy forceps, polypectomy snares).

  2. Size of Adenomas Detected [ Time Frame: 1 hour ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03807089


Sponsors and Collaborators
Massachusetts General Hospital
Pentax Medical
Investigators
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Principal Investigator: Norman S Nishioka, MD Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Norman Nishioka, MD, Massachusetts General Hospital:

Publications:

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Responsible Party: Norman Nishioka, MD, Director of Endoscopy, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03807089     History of Changes
Other Study ID Numbers: 2014P000677
First Posted: January 16, 2019    Key Record Dates
Results First Posted: July 16, 2019
Last Update Posted: July 16, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Norman Nishioka, MD, Massachusetts General Hospital:
Colonoscopy
colon cancer screening
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms