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Completed
NCT05628441
Real-time Computer Aided Detection of Barrett's Neoplasia
Conditions: Barrett Esophagus, Barrett Adenocarcinoma
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: 1
Enrollment: 30
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Location: Netherlands
Summary
In the real-time pilot study, the performance of a recently developed Computer Aided Detection (CADe) system will be investigated in 30 patients during real-time live endoscopic examination.
Three expert endoscopists in the field of Barrett's esophagus and endoscopic resection techniques will perform the inclusions following a standardized data acquisition protocol.
In total, 15 patients with a visible neoplastic lesion in their Barrett's esophagus and 15 patients without any visible abnormalities in their Barrett's esophagus will be included in this study.
Outcomes: to investigate feasibility of the use of the CADe system in the endoscopy suite, to investigate the performance of the CADe system when used by endoscopists.
Eligibility Criteria
Inclusion Criteria:Age > 18 years;Patients under surveillance for their diagnosed non-dysplastic Barrett's esophagus or patients refered for endoscopic treatment because of proven high-grade dysplasia or adenocarcinoma;A circumferential Barrett length of at least 2cmExclusion Criteria:Medical history of prior surgical or endoscopical treatment for neoplasia in their esophagusReflux esophagitis > grade 2 (LA classification)Inability to undergo endoscopic treatment and/or biopsies
Source: ClinicalTrials.gov (NCT05628441). StuddyBuddy aggregates publicly available trial information.