Skip to main content
Clinical Trials/NCT03807089
NCT03807089
Completed
Not Applicable

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

Massachusetts General Hospital0 sites283 target enrollmentJuly 1, 2014
ConditionsColonoscopy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colonoscopy
Sponsor
Massachusetts General Hospital
Enrollment
283
Primary Endpoint
Percentage of Patients With At Least One Adenoma
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2014
End Date
May 11, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Norman Nishioka, MD

Director of Endoscopy

Massachusetts General Hospital

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

Outcomes

Primary Outcomes

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 Outcomes

  • Mean Number of Adenomas Identified Per Patient With Polyps(1 hour)
  • Overall Polyp Detection Rate(1 hour)

Similar Trials