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ColoAssist vs. MEI

NCT01895504 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 475

Last updated 2015-03-04

No results posted yet for this study

Summary

Colonoscopy aims to investigate the entire colon by advancing the colonoscope tip from the rectum to the cecum, a process called cecal intubation. Cecal intubation may be difficult for different reasons, and features of the colonoscope and the use of imaging devices may influence the success rate. We want to compare the performance of a new colonoscope with novel features including gradual stiffness with that of a colonoscope supplied with a magnetic endoscope imaging (MEI) device. The hypothesis is that the performance of the new instrument is non-inferior to the MEI system.

Conditions

Interventions

DEVICE

ColoAssist

Screening colonoscopy with the test instrument

DEVICE

MEI

Colonoscopy with Olympus colonoscopes and MEI guidance

Sponsors & Collaborators

  • Sorlandet Hospital HF

    lead OTHER_GOV

Principal Investigators

  • Kjetil K Garborg, MD · SSHF Kristiansand, Norway

  • Michael Bretthauer, PhD · University of Oslo

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
66 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-06-30
Completion
2014-07-31

Countries

  • Norway

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 NCT01895504 on ClinicalTrials.gov