NCT05628441

Real-time Computer Aided Detection of Barrett's Neoplasia

Real-time Computer Aided Detection of Barrett's Neoplasia: a Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Detailed description

Patients in this study will undergo a scheduled surveillance endoscopy (according to current guidelines; n = 15) or are referred to a tertiary referral center for endoscopic resection of a possible neoplastic area in their known Barrett's esophagus (n = 15). Patients will be consciously sedated (standard care) before start of the procedure. During the endoscopic procedure, the endoscopist follows the standard protocol after extensive cleaning of the Barrett's segment: first, a standardized pullback video will be recorded, followed by a careful inspection of the Barrett segment every 2 centimeters. Per 2cm, a video of 10 seconds and 3 overview images are being recorded. During the imaging protocol, the CADe system presents its prediction on a second screen, next to the main endoscopy monitor. After the imaging protocol, standard clinical care is being resumed.

Conditions

• Barrett Esophagus
• Barrett Adenocarcinoma

Interventions

Type	Name	Description
OTHER	Computer Aided Detection system for Barrett's neoplasia	CADe system running in the back, not directly interfering with patient care

Timeline

• Start date: 2022-05-16
• Primary completion: 2022-10-13
• Completion: 2022-10-13
• First posted: 2022-11-28
• Last updated: 2022-11-28

Locations

1 site across 1 country: Netherlands