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Detection of Colorectal Cancer in Patients With a Positive Fecal Immunochemical Test Using an Electronic Nose Device (AeoNoseTM)

NCT03346005 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3345

Last updated 2020-03-16

No results posted yet for this study

Summary

The present study aims to investigate the diagnostic accuracy of exhaled breath analysis with the Aeonose (the eNose Company, Zutphen, the Netherlands) to distinguish the breath of patients suspected for CRC (based on a positive fecal immunochemical test), who are truly diagnosed with CRC, from patients suspected for CRC in whom this diagnosis is rejected after colonoscopy.

Conditions

Interventions

DEVICE

Aeonose

An electronic nose device is an artificial olfactory system that analyses volate organic compounds (VOCs) in exhaled breath. The AeonoseTM is a handheld device of 650 gram. A nose clip will be used to prevent the entry of non-filtered air and patients will be instructed to enclose the mouthpiece with their mouth at all times. A measurement cycle lasts for about 15 minutes, of which 5 minutes of in-and exhalation by the patient takes place.

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Peter D Siersema, MD · Radboud University Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-09
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Netherlands

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 NCT03346005 on ClinicalTrials.gov