Evaluation of a computer system for detecting Barrett's neoplasia
Real-life Prospective Evaluation of Computer-aided Detection (CAD) of Barrett's Neoplasia: MetaVision Study
This study is testing a new computer system to see if it can help doctors find abnormal cell changes in patients with Barrett's esophagus during routine check-ups.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 127 (estimated) |
| Sex | All |
| Sponsor | Portsmouth Hospitals NHS Trust Government |
| Locations | 1 site (Portsmouth, Hampshire) |
| Trial ID | NCT05965921 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the WISE VISION® computer-aided detection (CAD) system in identifying Barrett's neoplasia during gastroscopy procedures. Patients with Barrett's oesophagus will undergo regular surveillance gastroscopies, where the CAD system will assist in detecting abnormal cell changes. The goal is to improve the accuracy of targeted biopsies and potentially eliminate the need for extensive non-targeted biopsies, which are currently labor-intensive and costly. This real-life prospective evaluation aims to validate the CAD system's performance in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a known diagnosis of Barrett's oesophagus who are scheduled for routine gastroscopy.
Not a fit: Patients who have recently undergone ablation therapy or have conditions that impair the assessment of Barrett's neoplasia will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of cancerous changes in Barrett's oesophagus, improving patient outcomes and survival rates.
How similar studies have performed: While previous studies have validated CAD systems in controlled environments, this is one of the first real-life evaluations of such technology for Barrett's neoplasia detection.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Anyone aged 18 years and above * Known Barrett's oesophagus and having a gastroscopy for Barrett's surveillance or assessment of known neoplasia. * Participant is willing and able to give informed consent for participation in the study Exclusion Criteria: * Recent ablation therapy (HALO, APC) to Barrett's oesophagus in the last 6 weeks * Oesophageal disorder and patient's factors which impairs the ability of endoscopist to adequately assess of Barrett's neoplasia. This includes but not just limiting to severe oesophagitis, candidiasis, and poor patient tolerance.
Where this trial is running
Portsmouth, Hampshire
- Queen Alexandra Hospital, Portsmouth Hospitals University NHS trust — Portsmouth, Hampshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Pradeep Bhandari — Queen Alexandra Hospital, Portsmouth Hospitals University NHS Trust
- Study coordinator: Hein Htet, MBBS
- Email: hein.htet@porthosp.nhs.uk
- Phone: +44 23 9228 6000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.