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OpenTrials
Completed

NCT Number: NCT03807089

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

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.

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Key information

Conditions

Colonoscopy

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Conventional Pediatric Colonoscope

Device

Other names: Pentax Model EG-2490K

Short-Turn Radius Colonoscope

Device

Other names: Pentax Model EC-3490TLi

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Pentax Medical

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 16, 2019
Registry last updated
Jul 16, 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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