MedTrace Logo

Trial on Innovative Technologies in Colonoscopy

NCT01688557 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2016-10-07

No results posted yet for this study

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 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.

Conditions

Interventions

DEVICE

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

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

DEVICE

Conventional colonoscopy (Olympus CF-H180DL)

Conventional colonoscopy performed without innovative techniques used in experimental arm.

Sponsors & Collaborators

  • Specialist Diagnostic and Therapeutic Center MEDICINA

    collaborator UNKNOWN

  • Jagiellonian University

    lead OTHER

Principal Investigators

  • Miroslaw Szura, MD, PhD · I Department of General Surgery, Jagiellonian University

  • Radoslaw Pach, MD, PhD · I Department of General Surgery, Jagiellonian University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01688557 on ClinicalTrials.gov