Trials / Completed
CompletedNCT04673136
Usefulness of GI-GENIUS in FIT-based Colorectal Cancer Screening Program.
Usefulness of GI-GENIUS in FIT-based Colorectal Cancer Screening Program. Randomized Controlled Trial.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 3,400 (actual)
- Sponsor
- Asociación Española de Gastroenterología · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Deep learning technology has an increasing role in medical image applications and, recently, an artificial intelligence device has been developed and commercialized by Medtronic for identification of polyps during colonoscopy (GI-GENIUS). This kind of computer-aided detection (CADe) devices have demonstrated its ability for improving polyp detection rate (PDR) and the adenoma detection rate (ADR). However, this increase in PDR and ADR is mainly made at the expense of small polyps and non advanced adenomas. Colonoscopies after a positive fecal immunochemical test (FIT) could be the scenario with a higher prevalence of advanced lesions which could be the ideal situation for demonstrating if these CADe systems are able also to increase the detection of advanced lesions and which kind of advanced lesions are these systems able to detect. The CADILLAC study will randomize individuals within the population-based Spanish colorectal cancer screening program to receive a colonoscopy where the endoscopist is assisted by the GI-GENIUS device or to receive a standard colonoscopy. If our results are positive, that could suppose a big step forward for CADe devices, in terms of definitive demonstration of being of help for efectively identify also advanced lesions.
Conditions
- Colorectal Neoplasms
- Intestinal Neoplasms
- Gastrointestinal Neoplasms
- Colonic Polyp
- Colorectal Cancer
- Adenoma Colon
- Serrated Adenoma
- Serrated Polyp
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GI-GENIUS Medtronic | Colonoscopy assisted by GI-GENIUS device |
| OTHER | Colonoscopy | Standard colonoscopy |
Timeline
- Start date
- 2021-04-01
- Primary completion
- 2022-03-31
- Completion
- 2022-03-31
- First posted
- 2020-12-17
- Last updated
- 2022-04-08
Locations
6 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT04673136. Inclusion in this directory is not an endorsement.