Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-01-06 @ 1:14 AM
Study NCT ID:
NCT05512793
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2022-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Validation of PolyDeep: an Artificial Intelligence-based Computer-aided Polyp Detection (CADe) and Characterization (CADx) System. Polydeep Advance 2.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Patients who fulfill criteria will be randomly allocated to perform the first withdrawal with the standard technique versus PolyDeep assisted colonoscopy. All colorectal detected polyps will be resected. After a second cecal intubation, second withdrawal will be performed with the opposite technique'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2022-08-22', 'studyFirstSubmitQcDate': '2022-08-22', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adenoma miss rate (AMR)', 'timeFrame': '1 Year', 'description': 'AMR will be calculated as the number of adenomas detected on the withdrawal or portion in either group divided by the total number of adenomas detected during both withdrawals'}], 'secondaryOutcomes': [{'measure': 'Polyp miss rate', 'timeFrame': '1 Year', 'description': 'It will be calculated as the number of polyps detected on the withdrawal or portion in either group divided by the total number of polyps detected during both withdrawals'}, {'measure': 'Serrated lesions miss rate', 'timeFrame': '1 Year', 'description': 'It will be calculated as the number of serrated lesions detected on the withdrawal or portion in either group divided by the total number of serrated lesions detected during both withdrawals'}, {'measure': 'Diagnostic yield and lesions characterization', 'timeFrame': '1 Year', 'description': 'The diagnostic yield will be measure using sensitivity , specificity, Positive Predictive Value, Negative Predictive Value, likelihood ratios and Youden index. Histological diagnosis will be used as the gold standard.'}, {'measure': 'Withdrawal time. (First/second colonoscopy)', 'timeFrame': '1 Year', 'description': 'Withdrawal time between the two arms will be calculated and compared.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal Adenoma', 'Colorectal Serrated Lesions', 'Colorectal Polyps', 'Computer-Aided polyp Detection (CAD)'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '30245076', 'type': 'BACKGROUND', 'citation': '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': '24693890', 'type': 'BACKGROUND', 'citation': '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': '30738046', 'type': 'BACKGROUND', 'citation': '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': '25597420', 'type': 'BACKGROUND', 'citation': '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': '30296432', 'type': 'BACKGROUND', 'citation': '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': '32119927', 'type': 'BACKGROUND', 'citation': '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': '32598963', 'type': 'BACKGROUND', 'citation': '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': '26782820', 'type': 'BACKGROUND', 'citation': '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': '34172255', 'type': 'BACKGROUND', 'citation': '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': '24054741', 'type': 'BACKGROUND', 'citation': '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': '31446179', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://polydeep.org/', 'label': 'Polydeep website'}, {'url': 'https://linkinghub.elsevier.com/retrieve/pii/S246812531930411X', 'label': 'Effect of a deep-learning computer-aided detection system on adenoma detection during colonoscopy (CADe-DB trial): a double-blind randomised study.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Colorectal cancer (CRC) is the most frequently cancer in western world. A fundamental tool for detection and prevention is the colonoscopy. The detection and endoscopic resection of colorectal polyps, the precursor lesion of CRC, can reduce CRC incidence and mortality. Adenoma detection rate is the most used endoscopic quality indicator. The improvement of this indicator is related to the reduction of postcolonoscopy CRC incidence and mortality.\n\nColorectal polyp diagnosis is based on endoscopic resection and histological analysis. An accurate optical diagnosis could avoid histological lesion of smaller lesions, reducing the costs associated with histological diagnosis. The NICE (NBI International Colorectal Endoscopic) Classification has proposed the use of high definition endoscopes that have Narrow Band Imaging. However, NICE must be used by endoscopists who are sufficiently prepared and who have overcome the learning curve. Therefore, optical histology diagnosis with high accuracy independently of the center and the endoscopist is necessary.\n\nComputer Aid Diagnosis (CAD) systems based on Artificial Intelligence are experiencing exponential development in the field of medical image analysis. The development of the CAD system is based on the creation of large databases of endoscopic images and/or videos, on the training, development and validation of diagnostic algorithms in such databases and, finally, on prospective clinical validation in patients undergoing colonoscopy. The goal of CAD systems in colonoscopy is double. First, it aims to increase the detection of polyps (CADe) in general, and of adenomas and serrated lesions in particular. The second objective is to characterize (CADx) the histology of detected lesion.\n\nPolyDeep CAD is a functional prototype. It is capable of detecting, locating and classifying colorectal polyps. In vivo validation data shows that PolyDeep has high diagnostic accuracy for polyp identification and that this accuracy can be accommodated This clinical trial is part of the clinical validation of PolyDeep. We will perform a randomized clinical trial with a tandem colonoscopy design with adenoma miss rate as the main objective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First diagnostic colonoscopy performed after a positive fecal immunochemical test performed within the CRC screening program.\n* Surveillance after colorectal adenomas resection.\n* Authorization after reading the information sheet and singing the informed consent.\n\nExclusion Criteria:\n\n* Incomplete colonoscopy without cecal intubation.\n* Colonoscopies with insufficient intestinal cleansing (Boston Bowel Preparation Scale \\<6 or \\<2 in any of the evaluated segments).\n* Detected lesions without histological diagnosis.\n* Previous CRC.\n* Previous colonic resection.\n* CRC associated hereditary syndrome.\n* Serrated polyposis syndrome.'}, 'identificationModule': {'nctId': 'NCT05512793', 'briefTitle': 'Clinical Validation of PolyDeep: an Artificial Intelligence-based Computer-aided Polyp Detection (CADe) and Characterization (CADx) System. Polydeep Advance 2.', 'organization': {'class': 'OTHER', 'fullName': 'Fundacin Biomedica Galicia Sur'}, 'officialTitle': 'PolyDeep Advance 2: Clinical Validation of PolyDeep. Randomized Clinical Trial with a Tandem Colonoscopy Design.', 'orgStudyIdInfo': {'id': 'PolyDeep Advance 2.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Technique followed by Combination', 'description': 'Back-to-back tandem colonoscopies by the same endoscopist. The first colonoscopy will be performed without PolyDeep (standard technique) followed immediately by another colonoscopy with PolyDeep (combination technique).', 'interventionNames': ['Diagnostic Test: Standard technique First colonoscopy without PolyDeep']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combination followed by Standard Technique', 'description': 'Back-to-back tandem colonoscopies by the same endoscopist. In this arm, the first colonoscopy with be performed with PolyDeep (combination technique) followed immediately by another colonoscopy without PolyDeep (standard technique)', 'interventionNames': ['Diagnostic Test: Combination technique First colonoscopy with PolyDeep']}], 'interventions': [{'name': 'Standard technique First colonoscopy without PolyDeep', 'type': 'DIAGNOSTIC_TEST', 'description': 'Standard technique First colonoscopy without PolyDeep', 'armGroupLabels': ['Standard Technique followed by Combination']}, {'name': 'Combination technique First colonoscopy with PolyDeep', 'type': 'DIAGNOSTIC_TEST', 'description': 'Combination technique First colonoscopy with PolyDeep', 'armGroupLabels': ['Combination followed by Standard Technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32002', 'city': 'Ourense', 'state': 'Ourense', 'country': 'Spain', 'facility': 'Complexo Hospitalario Universitario de Ourense', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}, {'zip': '36071', 'city': 'Pontevedra', 'state': 'Pontevedra', 'country': 'Spain', 'facility': 'Complexo Hospitalario Universitario de Pontevedra', 'geoPoint': {'lat': 42.431, 'lon': -8.64435}}, {'zip': '36211', 'city': 'Vigo', 'country': 'Spain', 'facility': 'Hospital Álvaro Cunqueiro', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacin Biomedica Galicia Sur', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministerio de Ciencia e Innovación, Spain', 'class': 'OTHER_GOV'}, {'name': 'Asociación Española de Gastroenterología', 'class': 'OTHER'}, {'name': 'Ministry of Work and Welfare - Xunta de Galicia', 'class': 'OTHER_GOV'}, {'name': 'European Regional Development Fund', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}