Using AI to evaluate gastrointestinal neoplasms during endoscopy
Collection of Endoscopic Images and Videos for Validation of Artificial Intelligence Algorithms for Computer Aided Detection and Characterisation of Early Gastrointestinal Neoplasia
This study is testing if artificial intelligence can help doctors find and understand early signs of stomach and intestinal tumors during routine endoscopy procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1650 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Portsmouth Hospitals NHS Trust Government |
| Locations | 1 site (Portsmouth, Hampshire) |
| Trial ID | NCT04937647 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate and optimize artificial intelligence algorithms for the detection and characterization of early gastrointestinal neoplasia. It will be conducted in two phases: the first phase involves using anonymized endoscopic images and videos to fine-tune the AI algorithm's accuracy, while the second phase evaluates the algorithm's performance on a prospective basis. The study relies on expert assessments and histological diagnoses as the standard for comparison. Importantly, all data collection occurs during routine endoscopic procedures without additional interventions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who require gastroscopy or colonoscopy for gastrointestinal symptoms or surveillance of GI neoplasia.
Not a fit: Patients with severe oesophagitis or those with poor bowel preparation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of early detection of gastrointestinal neoplasms, potentially leading to better patient outcomes.
How similar studies have performed: While the use of AI in medical imaging is gaining traction, this specific approach to gastrointestinal neoplasms is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: -The participant must meet ALL of the following criteria to be considered eligible for the study: * Male or Female, aged 18 years or above. * Requiring gastroscopy and/or colonoscopy to investigate gastrointestinal symptoms, or as part of screening or ongoing surveillance of GI neoplasia. * Participant is willing and able to give informed consent for participation in the study. Exclusion Criteria The participant may not enter the study if ANY of the following apply: * Patients with endoscopically active severe oesophagitis * Poor bowel preparation
Where this trial is running
Portsmouth, Hampshire
- Portsmouth Hospitals NHS University Trust — Portsmouth, Hampshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Pradeep Bhandari, Prof — Portsmouth Hospitals NHS Trust
- Study coordinator: Laura Marshall
- Email: Laura.Marshall2@porthosp.nhs.uk
- Phone: 02392286000
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.