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

Mass General Brigham

Status: Completed

Conditions: Colonoscopy

Treatments: Device: Short-Turn Radius Colonoscope; Device: Conventional Pediatric Colonoscope

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03807089

2014P000677

Details and patient eligibility

About

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.

Enrollment: 283 patients

Sex: All

Ages: 40+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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283 participants in 2 patient groups

Short-Turn Radius Colonoscope

Experimental group

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 The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.

Treatment:

Device: Short-Turn Radius Colonoscope

Conventional Pediatric Colonoscope

Active Comparator group

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.

Treatment:

Device: Conventional Pediatric Colonoscope