Adenoma Clinical Trial
— GENIAL-CO FUOfficial title:
Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in Follow-up Patients in a Screening Setting
NCT number | NCT06160466 |
Other study ID # | NP4451 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 16, 2020 |
Est. completion date | May 1, 2024 |
The goal of this clinical trial is to evaluate the diagnostic yield of CADe in a consecutive population undergoing colonoscopy. The main question it aims to answer is the Adenoma Detection Rate (ADR). Participants undergoing colonoscopy for follow-up in a screening setting will be randomized in a 1:1 ratio to either receive Computer-Aided Detection (CADe) colonoscopy or a conventional colonoscopy (CC). GI Genius is the AI software that will be used in the present trial and is intended to be used as an adjunct to colonic endoscopy procedures to help endoscopists to detect in real time mucosal lesions (such as polyps and adenomas, including those with flat (non-polypoid) morphology) during standard screening and surveillance endoscopic mucosal evaluations. It is not intended to replace histopathological sampling as a means of diagnosis.Researchers will compare the CADe group and the CC-group to see if CAD-e can increase the ADR significantly.
Status | Recruiting |
Enrollment | 1160 |
Est. completion date | May 1, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 74 Years |
Eligibility | Inclusion Criteria: - Patients aged 50 to 74 undergoing colonoscopy examination following a prior colonsocopy were polyps were found (follow-up) performed in the context of a regional mass-screening program. Exclusion Criteria: - Patients unwilling or unable to give informed consent. - Patients reporting use of anti-platelet agents or anticoagulants precluding removal of polyps. |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Poliambulanza | Brescia | Bs |
Lead Sponsor | Collaborator |
---|---|
Fondazione Poliambulanza Istituto Ospedaliero |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of advanced adenomas | The percentage of patients with adenomas with high-grade displasia in CADe colonoscopy group will be recorded and compared with the rate of patients with adenomas with high-grade displasia in standard colonoscopy group. | When available the histological report of polyps removed (up to 3 weeks). | |
Primary | Rate of patients detected with 3 or more adenomas. | The percentage of patients with 3 or more adenomas (serrated adenomas will also be considered in the calculation) in CADe colonoscopy group will be compared with the rate of patients with 3 or more adenomas (including serrated adenomas) in standard colonoscopy group. | When available the histological report of polyps removed (up to 3 weeks). | |
Secondary | Overall adenoma and polyp detection rate, flat adenoma and serrated polyps/adenomas. | The percentage of adenomas, polyps (in general), flat adenoma and serrated polyps/adenoma detected will be recorded and compared between the groups. | When available the histological report of polyps removed (up to 3 weeks). | |
Secondary | Size of lesions detected | The size of lesion detected will be measured in millimiters and compared between the groups. | Immediately after the procedure. | |
Secondary | Rate of neoplasia by colonic site | The percentage of patients with neoplasia of proximal (right colonic segments) or distal (left colonic segments and rectum) site will be assessed and compared between the groups. | Immediately after the procedure. | |
Secondary | Post-colonoscopy surveilance | the time interval, expressed in years, to the next suggested follow-up colonoscopy will be assessed and compared between the groups. | When available the histological report of polyps removed (up to 3 weeks). | |
Secondary | Time of cecal intubation. | The time to reach the cecum will be measured in minutes, recorded and compared between the groups. | Immediately after the procedure. | |
Secondary | Withdrawal and total procedure time. | The time of withdrawal (from cecum to anus) and of the overall colonoscopy (from anus to anus) will be measured in minutes, recorded and compared between the groups. | Immediately after the procedure. | |
Secondary | Learning curve. | The above-mentioned outcomes will be calculated for each endoscopist at 3, 6, 9 and 12 months. | 3, 6, 9 and 12 months. | |
Secondary | Specific contribution of AI | Proportion of patients diagnosed with polyps which were detected only by Artificial intelligence | Immediately after the procedure. |
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