NCT05513261Completed
Clinical Validation of PolyDeep: an Artificial Intelligence-based Computer-aided Polyp Detection (CADe) and Characterization (CADx) System. Polydeep Advance 3
PolyDeep Advance 3: Randomized Clinical Trial Comparing High Definition Colonoscopy With PolyDeep Assisted High Definition Colonoscopy.
Source: ClinicalTrials.gov · Last updated 24 Feb 2025
Brief summary (registry, in English)
This study is a clinical validation of PolyDeep, a computer-aided polyp detection (CADe) and characterization (CADx) system. PolyDeep Advance 3 is a multicentric randomized clinical trial comparing high definition colonoscopy with PolyDeep assisted high definition colonoscopy. The hypothesis of the study is that the PolyDeep assisted colonoscopy increases the Adenoma Detection Rate (ADR).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 857 (actual)
- First submitted
- 22 Aug 2022
- Start date
- 17 Nov 2023
- Primary completion date
- 8 Mar 2024
- Lead sponsor
- Fundacin Biomedica Galicia Sur
- Diseases
- Colorectal cancer
- NCT number
- NCT05513261
What you commit to
- Study type: Interventional
- Participants enrolled: 857
- From 17 Nov 2023 to the primary completion date, 8 Mar 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous CRC
- Previous colonic resection.
Other illness
- Hereditary CRC syndromes
- Serrated polyposis syndrome
Other
- Colonoscopies with insufficient intestinal cleansing (Boston Bowel Preparation Scale \<6 or \<2 in any of the evaluated segments).
- Incomplete colonoscopy without cecal intubation.
Who the study is looking for
- First diagnostic colonoscopy performed after a positive fecal immunochemical test performed within the CRC screening program.
- Surveillance after resection of colorectal adenomas
- Acceptance after reading the information sheet and signing informed consent.
Age in the registry: 40 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Complexo Hospitalario Universitario de Ourense Coordinator of this site? Confirm its status | Ourense | Spain | Unknown status |
| Hospital de Montecelo Coordinator of this site? Confirm its status | Pontevedra | Spain | Unknown status |
| Hospital Álvaro Cunqueiro (Vigo) Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.