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ColonoscopyNCT03807089

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

A study testing Conventional Pediatric Colonoscope and Short-Turn Radius Colonoscope in people with Colonoscopy, run by Massachusetts General Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Colonoscopy
What is being tested?
Conventional Pediatric Colonoscope and Short-Turn Radius Colonoscope
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
283 participants
Where
No sites listed yet
Study dates
1 Jul 2014to 11 May 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Poor or Fair Bowel Prep
  • Difficult First Insertion
  • Familial Polyposis
  • Inflammatory Bowel Disease
  • Pregnancy
  • Active GI Bleeding
Show all 11Show fewer
  • 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

About this study

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
Being tested
Conventional Pediatric Colonoscope, Short-Turn Radius Colonoscope
Keywords
Colonoscopy, colon cancer screening

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional Pediatric ColonoscopeDevice

    Also called Pentax Model EG-2490K

  • Short-Turn Radius ColonoscopeDevice

    Also called Pentax Model EC-3490TLi

Study groups in NCT03807089
Study groupRoleWhat they receive
Short-Turn Radius ColonoscopeExperimentalColonoscopy 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.
Receives: Device: Short-Turn Radius Colonoscope
Conventional Pediatric ColonoscopeActive comparatorColonoscopy 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.
Receives: Device: Conventional Pediatric Colonoscope

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 hour

Secondary outcomes (2)

  1. Overall Polyp Detection Rate

    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.

    Measured: 1 hour

  2. Mean Number of Adenomas Identified Per Patient With Polyps

    Compare average number of adenomas found per patient with polyps between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2019
  2. Study start1 Jul 2014
  3. Primary completion11 May 2017
  4. Study completion11 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
283 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03807089
Sponsor's protocol ID
2014P000677
Status last verified
Jun 2019
First submitted
11 Jan 2019
Last updated
16 Jul 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 8978338

  • 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.

    PubMed 8978337

  • 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.

    PubMed 19075198

  • 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.

    PubMed 20189513

  • 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.

    PubMed 15929759

  • 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.

    PubMed 20018280

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Pediatric Colonoscope and Short-Turn Radius Colonoscope in people with Colonoscopy, run by Massachusetts General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With At Least One Adenoma (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03807089, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.

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