Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-01-13 @ 9:35 PM
Study NCT ID:
NCT05318495
Status:
UNKNOWN
Last Update Posted:
2022-04-08
First Post:
2022-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dual Tandem Study - SC vs. CAD-EYE vs. CAD-EYE With G-EYE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 372}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-07', 'studyFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2022-04-07', 'lastUpdatePostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Additional adenoma detection yield', 'timeFrame': '6 weeks', 'description': 'additional adenoma detection yield (represented by the miss rate) of CAD-EYE and G-EYE® colonoscopy over standard coloscopy compared to the additional adenoma detection yield of CAD-EYE aided colonoscopy over standard colonoscopy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adenoma', 'Colo-rectal Cancer']}, 'descriptionModule': {'briefSummary': "Single-center, four-arm dual-tandem, randomized, open-label study involving the following devices:\n\n1. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).\n2. CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas.\n3. The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning.", 'detailedDescription': "Single-center, four-arm dual-tandem, randomized, open-label study involving the following devices:\n\n1. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).\n2. CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas.\n3. The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning.\n\nTotal of up to 372 patients will be randomized,186 to each of the two tandems"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Screening and surveillance population for Adenoma and CRC.\n2. The patient must understand and sign a written informed consent for the procedure.\n\nExclusion Criteria:\n\n1. Subjects with inflammatory bowel disease;\n2. Subjects with a personal history of hereditary polyposis syndrome;\n3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy;\n4. Subjects with diverticulitis or toxic megacolon;\n5. Subjects with prior colonic surgery (exclusion appendectomy)\n6. Subjects with a history of radiation therapy to abdomen or pelvis;\n7. Pregnant or lactating female subjects;\n8. Subjects who are currently enrolled in another clinical investigation.\n9. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator.\n10. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)\n11. Any patient condition deemed too risky for the study by the investigator'}, 'identificationModule': {'nctId': 'NCT05318495', 'briefTitle': 'A Dual Tandem Study - SC vs. CAD-EYE vs. CAD-EYE With G-EYE', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dr. Horst Schmidt Klinik GmbH'}, 'officialTitle': 'A Dual Tandem Study Comparing the Adenoma Detection and Miss-rate of SC to That of Artificial Intelligence (CAD-EYE) Aided Colonoscopy and to That of Artificial Intelligence (CAD-EYE) and G-EYE® Aided Colonoscopy.', 'orgStudyIdInfo': {'id': 'Dual Tandem'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard Colonoscopy+CAD-EYE followed by Standard Colonoscopy', 'description': 'CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas.\n\nThe Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).', 'interventionNames': ['Device: Standard Colonoscopy', 'Device: CAD-EYE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE', 'description': 'CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas.\n\nThe Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).', 'interventionNames': ['Device: Standard Colonoscopy', 'Device: CAD-EYE']}, {'type': 'EXPERIMENTAL', 'label': 'Standard Colonoscopy+CAD-EYE+G-EYE followed by Standard Colonoscopy', 'description': "CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas.\n\nThe Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).\n\nThe G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning.", 'interventionNames': ['Device: Standard Colonoscopy', 'Device: CAD-EYE', 'Device: G-EYE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE+G-EYE', 'description': "CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas.\n\nThe Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).\n\nThe G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning.", 'interventionNames': ['Device: Standard Colonoscopy', 'Device: CAD-EYE', 'Device: G-EYE']}], 'interventions': [{'name': 'Standard Colonoscopy', 'type': 'DEVICE', 'description': 'The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).', 'armGroupLabels': ['Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE', 'Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE+G-EYE', 'Standard Colonoscopy+CAD-EYE followed by Standard Colonoscopy', 'Standard Colonoscopy+CAD-EYE+G-EYE followed by Standard Colonoscopy']}, {'name': 'CAD-EYE', 'type': 'DEVICE', 'description': 'CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas.', 'armGroupLabels': ['Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE', 'Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE+G-EYE', 'Standard Colonoscopy+CAD-EYE followed by Standard Colonoscopy', 'Standard Colonoscopy+CAD-EYE+G-EYE followed by Standard Colonoscopy']}, {'name': 'G-EYE', 'type': 'DEVICE', 'description': "The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning.", 'armGroupLabels': ['Standard Colonoscopy followed by Standard Colonoscopy+CAD-EYE+G-EYE', 'Standard Colonoscopy+CAD-EYE+G-EYE followed by Standard Colonoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65199', 'city': 'Wiesbaden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ralf Kiesslich, Prof.', 'role': 'CONTACT', 'email': 'ralf.kiesslich@helios-gesundheit.de', 'phone': '49-611432421'}], 'facility': 'Helios Dr. Horst Schmidt Kliniken', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}], 'centralContacts': [{'name': 'Ralf Kiesslich, Prof.', 'role': 'CONTACT', 'email': 'Ralf.Kiesslich@helios-gesundheit.de', 'phone': '49-611432421'}], 'overallOfficials': [{'name': 'Ralf Kiesslich, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helios Dr. Horst Schmidt Kliniken Wiesbaden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Horst Schmidt Klinik GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Prof. Dr. Ralf Kiesslich', 'investigatorAffiliation': 'Dr. Horst Schmidt Klinik GmbH'}}}}