NL-OMON21425
Recruiting
Not Applicable
Screening for Barrett’s esophagus: accuracy of exhaled breath analysis using an electronic nose device - a validation study
ConditionsBarrett's esophagus
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.
Investigators
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- •Patients can be withdrawn from the study if: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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