Clinical Validation of Polydeep: an Artificial Intelligence-based Computer-aided Polyp Detection (CADe) and Characterization (CADx) System

NCT05514301 | Completed DMC

• 1 other identifier: PolyDeep Advance 1.0
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a clinical validation of Polydeep, a computer-aided polyp detection (CADe) and characterization (CADx) system. Polydeep Advance 1 is an unicentric prospective diagnostic tests trial with a paired study design. The hypothesis of the study is that Polydeep, a CAD system, is more sensitive than a blinded endoscopists for the detection of colorectal polyps in a high definition colonoscopy.

Conditions

Colorectal Cancer

Keywords

Colorectal adenomas; Colorectal polyps; Serrated lesions; Computer-Aided detection System (CAD)

Outcome Measures

Primary Outcomes (1)

• Sensitivity of polydeep vs high experienced endoscopist blinded to polydeep

  To compare the sensitivity of Polydeep to a high experienced endoscopist for colorectal polyp detection (adenoma or serrated lesion histologically confirmed)

  1 year

Secondary Outcomes (5)

• Sensitivity for serrated lesions detection.

  1 year

• Sensitivity for adenoma detection.

  1 year

• Sensitivity for advanced colonic lesions

  1 year

• Sensitivity for diminute lesions (≤5mm)

  1 year

• To compare the diagnostic yield of the optical diagnosis

  1 year

Study Arms (1)

Sensitivity of Polydeep vs high experienced endoscopists for colorectal polyp detection

EXPERIMENTAL

Both diagnostic interventions will be performed in all patients: High definition colonoscopy and Polydeep system.

Diagnostic Test: Sensitivity of Polydeep vs high experienced endoscopists for colorectal polyp detection

Interventions

Sensitivity of Polydeep vs high experienced endoscopists for colorectal polyp detection DIAGNOSTIC_TEST

Both diagnostic interventions will be performed in all patients 1. High definition colonoscopy performed by high experienced endoscopists blinded to Polydeep. 2. Polydeep: a CADe and CADx system. The gold standard will be the histological diagnosis of the lesion.

Sensitivity of Polydeep vs high experienced endoscopists for colorectal polyp detection

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 the informed consent

You may not qualify if:

• Colonoscopies with insufficient intestinal cleansing (Boston Bowel Preparation Scale \<6 or \<2 in any of the evaluated segments).
• Detected lesions without histologic diagnosis.
• Previous CRC
• Previous colonic resection
• Hereditary CRC syndromes
• Serrated polyposis syndrome
• Incomplete colonoscopy without cecal intubation.

Sponsors & Collaborators

• Fundacin Biomedica Galicia Sur: lead
• Ministerio de Ciencia e Innovación, Spain: collaborator
• Ministry of Work and Welfare - Xunta de Galicia: collaborator
• Asociación Española de Gastroenterología: collaborator
• European Regional Development Fund: collaborator

Study Sites (1)

Complexo Hospitalario Universitario de Ourense

Ourense, Ourense, 32002, Spain

Location

Related Publications (11)

• Cubiella 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 BACKGROUND

• Corley 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 BACKGROUND

• Zhao 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 BACKGROUND

• ASGE 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.

  PMID: 25597420 BACKGROUND

• Puig I, Lopez-Ceron M, Arnau A, Rosinol O, Cuatrecasas M, Herreros-de-Tejada A, Ferrandez A, Serra-Burriel M, Nogales O, Vida F, de Castro L, Lopez-Vicente J, Vega P, Alvarez-Gonzalez MA, Gonzalez-Santiago J, Hernandez-Conde M, Diez-Redondo P, Rivero-Sanchez L, Gimeno-Garcia AZ, Burgos A, Garcia-Alonso FJ, Bustamante-Balen M, Martinez-Bauer E, Penas B, Pellise M; EndoCAR group, Spanish Gastroenterological Association and the Spanish Digestive Endoscopy Society. Accuracy of the Narrow-Band Imaging International Colorectal Endoscopic Classification System in Identification of Deep Invasion in Colorectal Polyps. Gastroenterology. 2019 Jan;156(1):75-87. doi: 10.1053/j.gastro.2018.10.004. Epub 2018 Oct 6.

  PMID: 30296432 BACKGROUND

• Jin EH, Lee D, Bae JH, Kang HY, Kwak MS, Seo JY, Yang JI, Yang SY, Lim SH, Yim JY, Lim JH, Chung GE, Chung SJ, Choi JM, Han YM, Kang SJ, Lee J, Chan Kim H, Kim JS. Improved Accuracy in Optical Diagnosis of Colorectal Polyps Using Convolutional Neural Networks with Visual Explanations. Gastroenterology. 2020 Jun;158(8):2169-2179.e8. doi: 10.1053/j.gastro.2020.02.036. Epub 2020 Feb 29.

  PMID: 32119927 BACKGROUND

• Hassan C, Spadaccini M, Iannone A, Maselli R, Jovani M, Chandrasekar VT, Antonelli G, Yu H, Areia M, Dinis-Ribeiro M, Bhandari P, Sharma P, Rex DK, Rosch T, Wallace M, Repici A. Performance of artificial intelligence in colonoscopy for adenoma and polyp detection: a systematic review and meta-analysis. Gastrointest Endosc. 2021 Jan;93(1):77-85.e6. doi: 10.1016/j.gie.2020.06.059. Epub 2020 Jun 26.

  PMID: 32598963 BACKGROUND

• Parmar R, Martel M, Rostom A, Barkun AN. Validated Scales for Colon Cleansing: A Systematic Review. Am J Gastroenterol. 2016 Feb;111(2):197-204; quiz 205. doi: 10.1038/ajg.2015.417. Epub 2016 Jan 19.

  PMID: 26782820 BACKGROUND

• Parsa N, Rex DK, Byrne MF. Colorectal polyp characterization with standard endoscopy: Will Artificial Intelligence succeed where human eyes failed? Best Pract Res Clin Gastroenterol. 2021 Jun-Aug;52-53:101736. doi: 10.1016/j.bpg.2021.101736. Epub 2021 Feb 22.

  PMID: 34172255 BACKGROUND

• Wani S, Rastogi A. Narrow-band imaging in the prediction of submucosal invasive colon cancer: how "NICE" is it? Gastrointest Endosc. 2013 Oct;78(4):633-6. doi: 10.1016/j.gie.2013.06.015. No abstract available.

  PMID: 24054741 BACKGROUND

• Mangas-Sanjuan C, Santana E, Cubiella J, Rodriguez-Camacho E, Seoane A, Alvarez-Gonzalez MA, Suarez A, Alvarez-Garcia V, Gonzalez N, Lue A, Cid-Gomez L, Ponce M, Bujanda L, Portillo I, Pellise M, Diez-Redondo P, Herraiz M, Ono A, Pizarro A, Zapater P, Jover R; QUALISCOPIA Study Investigators. Variation in Colonoscopy Performance Measures According to Procedure Indication. Clin Gastroenterol Hepatol. 2020 May;18(5):1216-1223.e2. doi: 10.1016/j.cgh.2019.08.035. Epub 2019 Aug 22.

  PMID: 31446179 BACKGROUND

Related Links

• Polydeep website
• 43th congress of digestive endoscopy spanish society
• Effect of a deep-learning computer-aided detection system on adenoma detection during colonoscopy (CADe-DB trial): a double-blind randomised study.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A high definition colonoscopy will be performed by a high experienced endoscopists. The endoscopists will be blinded to a second monitor with the Polydeep evaluation. A second observer will annotate the lesions detected during colonoscopy withdrawal and will inform the endoscopists if Polydeep detects a lesion that is not detected by the endoscopists.

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: January 30, 2023
• Primary Completion: March 15, 2023
• Study Completion: April 11, 2023
• Last Updated: February 24, 2025

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)