Evaluation of a real-time computer aided detection and diagnosis system of Barrett's neoplasia during live endoscopic procedures: A multicenter prospective study

Evaluation of a real-time computer aided detection and diagnosis system of Barrett's neoplasia during live endoscopic procedures: A multicenter prospective study - Real-time CAD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56957

Enrollment

200

Registered

2024-08-06

Start date

2024-11-18

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Adenocarcinoma esophageal cancer

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - BE patients without prior treatment that are undergoing regular endoscopic surveillance, or an endoscopic treatment in the Barrett segment. - Age >= 18 years - Signed informed consent

Exclusion criteria

Exclusion criteria: - Prior endoscopic or surgical treatment of the esophagus for neoplasia - Reflux esophagitis > grade B (LA classification) - Inability to undergo EMR/ESD and/or obtain biopsies (e.g. due to anticoagulation, coagulation disorders, varices)

Design outcomes

Primary

Measure	Time frame
- Per patient combined CADe/CADx sensitivity (i.e. number of patients with a visible abnormality detected by CAD on at least one Barrett level, divided by the total number of neoplasia patients according to the gold standard).	—

Secondary

Measure	Time frame
- Per patient combined CADe/CADx specificity (i.e. number of patients without a visible abnormality where CAD does not identify a lesion on any level, divided by the total number of NDBE patients according to the gold standard). - Per level combined CADe/CADx sensitivity and specificity (i.e. number of levels with a visible abnormality identified by CADe/CADx, and number of levels without a visible abnormality where CADe/CADx does not identify a lesion; both divided by the total number of neoplasia/NDBE levels according to the gold standard). - Per patient and per level CADe sensitivity and specificity	—

Measure

Time frame

- Per patient combined CADe/CADx specificity (i.e. number of patients without a visible abnormality where CAD does not identify a lesion on any level, divided by the total number of NDBE patients according to the gold standard). - Per level combined CADe/CADx sensitivity and specificity (i.e. number of levels with a visible abnormality identified by CADe/CADx, and number of levels without a visible abnormality where CADe/CADx does not identify a lesion; both divided by the total number of neoplasia/NDBE levels according to the gold standard). - Per patient and per level CADe sensitivity and specificity

—

Countries

Netherlands

Outcome results