Clinical trial · Interventional
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.
NCT05513261CI-TRIAL-00086359completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High definition colonoscopy (standard colonoscopy) in Adenoma Detection Rate | Diagnostic Test | — | UNRESOLVED |
| PolyDeep assisted high definition colonoscopy (CAD system) in Adenoma Detection Rate | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Control arm: High definition colonoscopy
- description
- Diagnostic test: Standard colonoscopy
- interventionNames
- Diagnostic Test: High definition colonoscopy (standard colonoscopy) in Adenoma Detection Rate
- type
- EXPERIMENTAL
- label
- PolyDeep assisted high definition colonoscopy
- description
- Diagnostic test: PolyDeep
- interventionNames
- Diagnostic Test: PolyDeep assisted high definition colonoscopy (CAD system) in Adenoma Detection Rate
Primary outcomes (1)
- measure
- Adenoma Detection Rate (ADR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Colonoscopies with insufficient intestinal cleansing (Boston Bowel Preparation Scale \<6 or \<2 in any of the evaluated segments). * Incomplete colonoscopy without cecal intubation. * Previous CRC * Previous colonic resection. * Hereditary CRC syndromes * Serrated polyposis syndrome
References
Publications (12)
- BACKGROUNDCubiella J, Marzo-Castillejo M, Mascort-Roca JJ, Amador-Romero FJ, Bellas-Beceiro B, Clofent-Vilaplana J, Carballal S, Ferrandiz-Santos J, Gimeno-Garcia AZ, Jover R, Mangas-Sanjuan C, Moreira L, Pellise M, Quintero E, Rodriguez-Camacho E, Vega-Villaamil P; Sociedad Espanola de Medicina de Familia y Comunitaria y Asociacion Espanola de Gastroenterologia. Clinical practice guideline. Diagnosis and prevention of colorectal cancer. 2018 Update. Gastroenterol Hepatol. 2018 Nov;41(9):585-596. doi: 10.1016/j.gastrohep.2018.07.012. Epub 2018 Sep 20. English, Spanish. PMID 30245076
- BACKGROUNDCorley DA, Jensen CD, Marks AR, Zhao WK, Lee JK, Doubeni CA, Zauber AG, de Boer J, Fireman BH, Schottinger JE, Quinn VP, Ghai NR, Levin TR, Quesenberry CP. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med. 2014 Apr 3;370(14):1298-306. doi: 10.1056/NEJMoa1309086. PMID 24693890
- BACKGROUNDZhao S, Wang S, Pan P, Xia T, Chang X, Yang X, Guo L, Meng Q, Yang F, Qian W, Xu Z, Wang Y, Wang Z, Gu L, Wang R, Jia F, Yao J, Li Z, Bai Y. Magnitude, Risk Factors, and Factors Associated With Adenoma Miss Rate of Tandem Colonoscopy: A Systematic Review and Meta-analysis. Gastroenterology. 2019 May;156(6):1661-1674.e11. doi: 10.1053/j.gastro.2019.01.260. Epub 2019 Feb 6. PMID 30738046
- BACKGROUNDLiu A, Wang H, Lin Y, Fu L, Liu Y, Yan S, Chen H. Gastrointestinal endoscopy nurse assistance during colonoscopy and polyp detection: A PRISMA-compliant meta-analysis of randomized control trials. Medicine (Baltimore). 2020 Aug 21;99(34):e21278. doi: 10.1097/MD.0000000000021278. PMID 32846754
- BACKGROUNDASGE Technology Committee; Abu Dayyeh BK, Thosani N, Konda V, Wallace MB, Rex DK, Chauhan SS, Hwang JH, Komanduri S, Manfredi M, Maple JT, Murad FM, Siddiqui UD, Banerjee S. ASGE Technology Committee systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest Endosc. 2015 Mar;81(3):502.e1-502.e16. doi: 10.1016/j.gie.2014.12.022. Epub 2015 Jan 16.