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

NCT03807089 | Completed Results FDA Device

• 1 other identifier: 2014P000677
• Study Type: interventional
• Target: 283
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colonoscopy

Keywords

Colonoscopy; colon cancer screening

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With At Least One Adenoma

  Compare adenoma detection rate between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.

  1 hour

Secondary Outcomes (2)

• Overall Polyp Detection Rate

  1 hour

• Mean Number of Adenomas Identified Per Patient With Polyps

  1 hour

Other Outcomes (2)

• Size of Polyps Detected

  1 hour

• Size of Adenomas Detected

  1 hour

Study Arms (2)

Short-Turn Radius Colonoscope

EXPERIMENTAL

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 The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.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

Conventional Pediatric Colonoscope

ACTIVE COMPARATOR

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 The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.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

Interventions

Conventional Pediatric Colonoscope DEVICE

Also known as: Pentax Model EG-2490K

Conventional Pediatric Colonoscope

Short-Turn Radius Colonoscope DEVICE

Also known as: Pentax Model EC-3490TLi

Short-Turn Radius Colonoscope

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Pentax Medical: collaborator

Related Publications (6)

• 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.

  PMID: 8978338 BACKGROUND

• 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.

  PMID: 8978337 BACKGROUND

• 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.

  PMID: 19075198 BACKGROUND

• 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.

  PMID: 20189513 BACKGROUND

• 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.

  PMID: 15929759 BACKGROUND

• 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.

  PMID: 20018280 BACKGROUND

Results Point of Contact

• Title: Dr. Norman Nishioka
• Organization: Massachusetts General Hospital

nnishioka@partners.org

617-726-4422

Study Officials

• Norman S Nishioka, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endoscopy

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 16, 2019
• Study Start: July 1, 2014
• Primary Completion: May 11, 2017
• Study Completion: May 11, 2017
• Last Updated: July 16, 2019
• Results First Posted: July 16, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share