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Adenoma Detection Rate With Endocuff-Assisted Colonoscopy - an Italian Trial

NCT03612674 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2100

Last updated 2018-08-02

No results posted yet for this study

Summary

In European countries, colorectal cancer (CRC) represents an important public health problem. It is widely held view that most carcinomas develop from an adenoma-carcinoma progression.

Adenoma detection rate (ADR) is a marker of high quality colonoscopy and it was inversely associated with the risk of interval colorectal cancer, advanced-stage interval cancer, and fatal interval cancer after colonoscopy.

Although colonoscopy is considered the gold standard for adenoma detection, it has shown some limits, so industry has aimed at increasing detection rate of adenomas providing new technologies, most of witch to detect lesions located in blind spots.

ARC Endocuff Vision (AEV), the second generation of Endocuff, represents a new generation of these devices, thus assessing the diagnostic sensibility of ARC Endocuff Vision assisted colonoscopy (EAC) is an interesting challenge.

Aim of the study is to compare ADR of EAC versus standard colonoscopy among FIT positive subjects in the context of CRC screening programs.

Conditions

Interventions

PROCEDURE

Standard colonoscopy

Current standard of care colonoscopy.

DEVICE

ARC Endocuff Vision

Subjects randomized to undergo a colonoscopy procedure with ARC Endocuff Vision will have this device placed on the top of the colonoscope used during their procedure.

Sponsors & Collaborators

  • Veneto Tumor Registry, Azienda Zero, Padua, Italy

    collaborator UNKNOWN

  • Cancer Prevention and Research Institute, Italy

    lead OTHER

Principal Investigators

  • Gianni Amunni, MD · Oncological Network, Prevention and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-04
Primary Completion
2019-04-30
Completion
2019-08-31

Countries

  • Italy

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 NCT03612674 on ClinicalTrials.gov