Clinical trial · Observational
Real-time Computer Aided Detection of Barrett's Neoplasia
Real-time Computer Aided Detection of Barrett's Neoplasia: a Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Adenocarcinoma | Barrett Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Barrett Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computer Aided Detection system for Barrett's neoplasia | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- CADe system
- description
- All patients included in the study will undergo the endoscopic procedure according to standard clinical care and the study protocol. The CADe system will run in the back, not interfering with care.
- interventionNames
- Other: Computer Aided Detection system for Barrett's neoplasia
Primary outcomes (1)
- measure
- Combined performance of endoscopist + CADe system in terms of per-patient sensitivity and specificity
- timeFrame
- 5 months
- description
- To investigate the combined performance between endoscopist and CADe system on a per-patient level.
Secondary outcomes (1)
- measure
- Stand-alone performance of CADe system in terms of per-patient sensitivity and specificity
- timeFrame
- 5 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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 2cm Exclusion Criteria: * Medical history of prior surgical or endoscopical treatment for neoplasia in their esophagus * Reflux esophagitis \> grade 2 (LA classification) * Inability to undergo endoscopic treatment and/or biopsies
References
Publications (1)
- DERIVEDFockens KN, Jukema JB, Jong MR, Boers T, van der Putten JA, Kusters CHJ, Pouw RE, Duits LC, van der Sommen F, de With PH, de Groof AJ, Bergman JJ; BONS-AI consortium. The use of a real-time computer-aided detection system for visible lesions in the Barrett's esophagus during live endoscopic procedures: a pilot study (with video). Gastrointest Endosc. 2024 Sep;100(3):527-531.e3. doi: 10.1016/j.gie.2024.04.011. Epub 2024 Apr 9. PMID 38604297