Colonic Polyp Clinical Trial
Official title:
Comparing CADe Software for Enhanced Polyp Detection: A Randomized Controlled Trial
NCT number | NCT06077435 |
Other study ID # | 981840 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2023 |
Est. completion date | June 1, 2025 |
Purpose & Research Questions The purpose of this study is to evaluate whether artificial intelligence (AI) improves the detection of polyps and whether the system can classify the type and severity of detected changes. The investigators will also assess if there are any differences between the various AI systems and whether the polyps that may be missed are benign or malignant.
Status | Recruiting |
Enrollment | 915 |
Est. completion date | June 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 90 Years |
Eligibility | Inclusion Criteria: - Age > 50 years - Elective colonoscopy Exclusion Criteria: - Patient declines to participate in the study. - Age < 50 years - Emergency examinations - Contraindications for biopsy/polypectomy - Unprepared bowel |
Country | Name | City | State |
---|---|---|---|
Sweden | Sahlgrenska University Hospital | Gothenburg | Gothenbburg |
Lead Sponsor | Collaborator |
---|---|
Sahlgrenska University Hospital, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of Adenoma Detection Rates (ADR) between colonoscopies assisted by Artificial Intelligence (AI) and conventional colonoscopies without AI | The ADR is typically expressed as a percentage and is calculated using the following formula:Number of colonoscopies with adenoma detection/ Total number of colonoscopies
×100. |
During procedure (up to 40 minutes) | |
Secondary | To compare the effectiveness of AI systems in characterizing polyps with conventional histology | Two of the AI systems include a characterization feature, and this assessment will be compared to conventional histology | During procedure (up to 40 minutes) |
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