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Clinical Trials/NL-OMON21425
NL-OMON21425
Recruiting
Not Applicable

Screening for Barrett’s esophagus: accuracy of exhaled breath analysis using an electronic nose device - a validation study

Radboudumc0 sites980 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Barrett's esophagus
Sponsor
Radboudumc
Enrollment
980
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational non invasive

Investigators

Sponsor
Radboudumc

Eligibility Criteria

Inclusion Criteria

  • Aged 18 years or older
  • \-Undergoing a clinically indicated (surveillance) endoscopy
  • \-Able to give signed informed consent
  • 1\.Patients with known BE (defined as \=1 cm of columnar mucosa with histopathologic confirmation of intestinal metaplasia without dysplasia)
  • 2\.Individuals with GERD symptoms without BE (GERDQ\-score \=8 or the endoscopic presence of reflux esophagitis)
  • 3\.‘Healthy’ controls without BE or GERD

Exclusion Criteria

  • \-Patients with a history of any type of malignancy (not including basal\-cell skin cancer (BCC) and squamous\-cell skin cancer (SCC))
  • \-Prior surgical esophageal or gastric resection or prior ablative therapy
  • \-Patients who are unable to perform breathing maneuver needed for Aeonose\-analysis of exhaled breath
  • Withdrawal criteria after initial study inclusion:
  • Patients can be withdrawn from the study if:
  • \-Incomplete upper endoscopy
  • \-Active H. Pylori infection
  • \-BE segment \<1cm or no intestinal metaplasia in the esophagus
  • \-Intestinal metaplasia in the stomach

Outcomes

Primary Outcomes

Not specified

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