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Advanced Endoscopic Imaging in Colonoscopy

NCT02929381 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2016-10-11

No results posted yet for this study

Summary

The aim of the study is to evaluate the usefulness of high-tech endoscopy in clinical practice.

The important elements of this evaluation are:

* Evaluation of the character of neoplastic lesions in the colon based on different imaging techniques
* Verification of the endoscopic image with histopathologic descriptions
* Establishing the type of the lesion on the basis of Kudo and NICE classifications
* Comparison of the result of histopathological examination with the macroscopic type of the lesion
* Determination of the most advanced lesions (MAL)
* Comparison of the cecal intubation time
* Evaluation of the type of anesthesia used during colonoscopy
* Subjective assessment of the severity of pain according to VAS (visual analogue scale)
* Comparison of the accuracy of the location of lesions on the basis of endoscopic navigation
* Comparison of the total examination time
* Comparison of adenoma detection rate

Conditions

Interventions

DEVICE

Innovative colonoscopy (Olympus CF-HQ190L, NBI + Dual Focus)

NBI and Dual Focus options will be used to classify lesions according to Kudo and NICE 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

    collaborator OTHER

  • Miroslaw Szura

    lead OTHER

Principal Investigators

  • Miroslaw Szura, MD, PhD · Department of Experimental and Clinical Surgery, Jagiellonian University Medical College,

  • Artur Pasternak, MD, PhD · Department of Anatomy, Jagiellonian University Medical College

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
2016-06-30
Primary Completion
2017-06-30
Completion
2018-12-31

Countries

  • Poland

Study Locations

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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 NCT02929381 on ClinicalTrials.gov