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PolypsRCT-ICNCT01688557

Trial on Innovative Technologies in Colonoscopy

A study testing Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus) and Conventional colonoscopy (Olympus CF-H180DL) in people with Polyps and Neoplasms, run by Jagiellonian University at 2 sites in Poland.

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 trial will compare results of screening colonoscopy performed by means of conventional colonoscopy and using new visualisation techniques during endoscopic examination. Electronic colonoscopes Olympus CF-HQ190F with following options: magnetic positioning (Scope Guide), responsive insertion technology (RIT), dual… Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Polyps, Neoplasms, Inflammatory Bowel Disease
What is being tested?
Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus) and Conventional colonoscopy (Olympus CF-H180DL)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
2 sitesPoland
Study dates
Sep 2012to Sep 2016
Phase
Interventional
Are there results?
None posted in the registry

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • written informed consent
  • no previous abdominal surgery
  • no colonoscopy during last 10 years

Who cannot join

  • age < 40 and > 65 years
  • large bowel resection in history
  • colonoscopy performed during last 10 years
  • contraindications for general anaesthesia
  • ASA > IV
  • pregnancy
Show all 10Show fewer
  • confirmed neoplastic disease
  • cirrhosis (Child B or C) or ascites
  • immunosuppressive therapy or steroids intake
  • malabsorption syndrome

Trial locations and contacts

2 sites in 1 country.

Poland2 sites

  • Specialist Diagnostic and Therapeutic Center MEDICINA

    Krakow, Malopolska, 30-307

  • I Department of General Surgery, Jagiellonian University

    Krakow, Malopolska, 31-501

Other trials in Poland

About this study

Official title: Prospective Randomised Trial Comparing New Technologies of Endoscopic Bowel Visualisation With Conventional Colonoscopy.

The trial will compare results of screening colonoscopy performed by means of conventional colonoscopy and using new visualisation techniques during endoscopic examination.

  • Electronic colonoscopes Olympus CF-HQ190F with following options: magnetic positioning (Scope Guide), responsive insertion technology (RIT), dual focus function, narrow band imaging (NBI) will be used for innovative colonoscopies
  • Electronic colonoscopes Olympus CF-H180DL with Scope Guide and NBI options will be used for conventional colonoscopies Endoscopists will archive all images and establish presumptive diagnosis based on the results of different visualisation techniques. All endoscopes will be attached to Olympus Evis Exera III system. Biopsy of all pathological lesions will be performed to establish final diagnosis. The main outcome measure is diagnostic accuracy of innovative colonoscopy in comparison with conventional technique.
Read the detailed description

A total of 600 consecutive patients undergoing screening unsedated colonoscopy will be randomly assigned to innovative or conventional examination. Randomization will be based on computer-generated randomization lists. All patients will be blinded so they will not know which techniques will be used to assess lesions found in colon. In innovative colonoscopy group narrow band imaging (NBI) and Dual Focus (DF) function will be used to identify and classify all lesions acc. to Sano and Kudo classification. Endoscopic biopsy will be taken from all lesion and endoscopic diagnosis will be compared with final histological diagnosis. Thus sensitivity, specificity, diagnostic accuracy, predictive values, likelihood ratio and Youden index will be calculated. As secondary endpoints total examination time, coecal intubation rate and pain intensity (VAS scale) will be established. This study will help to establish whether new technologies used during colonoscopy may improve diagnostic possibilities and whether they prolong examination time or lead to increase of pain intensity afterwards.

Being tested
Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus), Conventional colonoscopy (Olympus CF-H180DL)
Keywords
narrow band imaging, dual focus, responsive insertion technique, scope guide, colonoscopy, colorectal cancer screening
Medical subject headings
Polyps, Neoplasms, Inflammatory Bowel Diseases

What participants receive

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

  • Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus)Device

    NBI and Dual Focus options will be used to classify lesions according to Sano and Kudo classifications.

  • Conventional colonoscopy (Olympus CF-H180DL)Device

    Conventional colonoscopy performed without innovative techniques used in experimental arm.

Study groups in NCT01688557
Study groupRoleWhat they receive
Innovative colonoscopyExperimentalInnovative colonoscopy performed using narrow band imaging and dual focus function (NBI + Dual Focus).
Receives: Device: Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus)
Conventional colonoscopyActive comparatorConventional colonoscopy performed without innovative techniques assessed in this study.
Receives: Device: Conventional colonoscopy (Olympus CF-H180DL)

What is being measured

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

  1. Diagnostic accuracy of innovative colonoscopy

    Diagnostic accuracy of innovative techniques used during colonoscopy (narrow band imaging and double focus option) will be assessed using StatSoft Statistica 10.0 software. All lesions will be classified acc. to Sano and Kudo classification during colonoscopy and results will be compared with histologic examination.

    Measured: 1 year

Secondary outcomes (3)

  1. Total examination time

    Time of the whole procedure (from insertion of the colonoscope to removing of the whole instrument) will be compared in conventional and innovative colonoscopy.

    Measured: 8-20 minutes

  2. Coecal intubation time

    Time from insertion of colonoscope to visualisation of the coecum - always confirmed by a snapshot.

    Measured: 5-15 minutes

  3. Pain intensity (VAS scale)

    Pain intensity will be assessed during and after each colonoscopy using the Visual Analogue Scale. It will be assessed immediately after colonoscopy, 15 min, 30 min, 1 hour and 2 hours after the procedure.

    Measured: 0-10

Timeline

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

  1. First posted20 Sep 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionSep 2016
  4. Study completionSep 2016

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01688557
Sponsor's protocol ID
Innovations in colonoscopy
Acronym
RCT-IC
Status last verified
Oct 2016
First submitted
16 Sep 2012
Last updated
7 Oct 2016
Results posted
No
Data monitoring committee
No

Publications

  • Szura M, Pasternak A, Bucki K, Urbanczyk K, Matyja A. Two-stage optical system for colorectal polyp assessments. Surg Endosc. 2016 Jan;30(1):204-14. doi: 10.1007/s00464-015-4186-x. Epub 2015 Apr 4.

    PubMed 25840894

  • Pasternak A, Szura M, Solecki R, Matyja M, Szczepanik A, Matyja A. Impact of responsive insertion technology (RIT) on reducing discomfort during colonoscopy: randomized clinical trial. Surg Endosc. 2017 May;31(5):2247-2254. doi: 10.1007/s00464-016-5226-x. Epub 2016 Sep 8.

    PubMed 27631316

  • Szura M, Pasternak A, Solecki R, Matyja M, Szczepanik A, Matyja A. Accuracy of preoperative tumor localization in large bowel using 3D magnetic endoscopic imaging: randomized clinical trial. Surg Endosc. 2017 May;31(5):2089-2095. doi: 10.1007/s00464-016-5203-4. Epub 2016 Aug 29.

    PubMed 27572063

Questions about this trial

What is this clinical trial studying?

A study testing Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus) and Conventional colonoscopy (Olympus CF-H180DL) in people with Polyps and Neoplasms, run by Jagiellonian University at 2 sites in Poland.

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 10 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 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Diagnostic accuracy of innovative colonoscopy (time frame: 1 year). 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 NCT01688557, which also lists 3 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 7 Oct 2016.

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