Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-01-01 @ 9:50 PM
Study NCT ID:
NCT06780358
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-17
First Post:
2025-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of bladdeR Cancer Detection in Standard White Light Versus AI-Supported Endoscopy-02
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Premarket Confirmatory, National, single-center, randomized, prospective, non-inferiority trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2025-01-13', 'studyFirstSubmitQcDate': '2025-01-13', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of standard WLC compared to WLC assisted by the AI model evaluated with a non-inferiority margin of 5%.', 'timeFrame': '7 month', 'description': 'To determine whether the AI model is non-inferior with regards to sensitivity compared to standard WLC in a randomized controlled trial.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to investigate if an artificial intelligence support tool is non-inferior in detecting bladder cancer compared to the traditional method, standard white light cystoscopy (WLC). The researchers will compare how well the artificial intelligence tool and WLC perform in detecting bladder cancer through a controlled, organized testing process.', 'detailedDescription': 'This clinical investigation aims to confirm that an artificial intelligence model utilizing a Convolutional Neural Network (CNN) can achieve sensitivity in detecting bladder cancer that is non-inferior to traditional white light cystoscopy (WLC) in a randomized controlled trial. The investigational artificial intelligence device leverages the advanced capabilities of CNNs, a type of deep learning model designed to analyze visual imagery with high precision.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women adults, age \\>18 years old\n\nSuspicion of primary or recurrent bladder cancer\n\nWillingness to sign the Informed Consent Form (ICF) for the CI\n\nAbility to comprehend the oral and written Patient Information Leaflet (PIL)\n\nExclusion Criteria:\n\n* Not able or willing to sign the Informed Consent Form'}, 'identificationModule': {'nctId': 'NCT06780358', 'acronym': 'RAISE02', 'briefTitle': 'Study of bladdeR Cancer Detection in Standard White Light Versus AI-Supported Endoscopy-02', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cystotech'}, 'officialTitle': 'Study of bladdeR Cancer Detection in Standard White Light Versus AI-Supported Endoscopy-02', 'orgStudyIdInfo': {'id': 'RAISE02-24-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'WLC detection', 'description': 'Detection of bladder cancer is conducted according to state-of-the-art procedures in white light modality.'}, {'type': 'EXPERIMENTAL', 'label': 'AI model - WLC supported detection', 'description': 'Detection of bladder cancer in white light supported by a pre-market AI-support tool.', 'interventionNames': ['Device: AI supported detection of bladder cancer']}], 'interventions': [{'name': 'AI supported detection of bladder cancer', 'type': 'DEVICE', 'description': 'AI-model-supported detection of bladder cancer during white light cystoscopy', 'armGroupLabels': ['AI model - WLC supported detection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Urology, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Jakobsen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Urology, Aarhus University Hospital, denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Sharing the IPD conflicts with the collaboration agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cystotech', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}