NCT05512793Completed
Clinical Validation of PolyDeep: an Artificial Intelligence-based Computer-aided Polyp Detection (CADe) and Characterization (CADx) System. Polydeep Advance 2.
PolyDeep Advance 2: Clinical Validation of PolyDeep. Randomized Clinical Trial with a Tandem Colonoscopy Design.
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 2 is a multicentric randomized clinical trial with a tandem colonoscopy design. The hypothesis of this study is that Polydeep assisted colonoscopy will reduce the number of missed adenomas in the first withdrawal.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 260 (actual)
- First submitted
- 22 Aug 2022
- Start date
- 24 May 2023
- Primary completion date
- 30 Jul 2023
- Lead sponsor
- Fundacin Biomedica Galicia Sur
- Diseases
- Colorectal cancer
- NCT number
- NCT05512793
What you commit to
- Study type: Interventional
- Participants enrolled: 260
- From 24 May 2023 to the primary completion date, 30 Jul 2023
- 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
- CRC associated hereditary syndrome.
- Serrated polyposis syndrome.
Other
- Incomplete colonoscopy without cecal intubation.
- Colonoscopies with insufficient intestinal cleansing (Boston Bowel Preparation Scale \<6 or \<2 in any of the evaluated segments).
- Detected lesions without histological diagnosis.
Who the study is looking for
- First diagnostic colonoscopy performed after a positive fecal immunochemical test performed within the CRC screening program.
- Surveillance after colorectal adenomas resection.
- Authorization after reading the information sheet and singing the 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 |
| Complexo Hospitalario Universitario de Pontevedra Coordinator of this site? Confirm its status | Pontevedra | Spain | Unknown status |
| Hospital Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.