Detection of Barrett's esophagus through exhaled breath using an electronic nose device (AeoNoseTM)
Recruiting
- Conditions
- Gastroesophageal reflux disease (GERD)Barrett's Esophagus (BE)Esophageal Adenocarcinoma (EAC)
- Registration Number
- NL-OMON26864
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 375
Inclusion Criteria
Subjects, who are:
- Aged 18 years or older.
Exclusion Criteria
•Patients with a history of any type of malignancy (not including basal-cell skin cancer (BCC) and squamous-cell skin cancer (SCC))
• Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation) or endoscopic mucosal resection.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The ability to distinguish between patients with BE, healthy individuals, and patients with reflux symptoms by eNose in terms of sensitivity, specificity and accuracy.
- Secondary Outcome Measures
Name Time Method Cross-validated accuracy with which the eNose can distinguish between patients with BE, healthy individuals and patients with reflux symptoms, defined as the percentage of correctly classified patients using the leave-some out method.<br /><br>- Acceptance rate of using the eNose