Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-30 @ 5:38 AM
Study NCT ID:
NCT06483503
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-10
First Post:
2024-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extra Wide Field of View Lens Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2024-06-18', 'studyFirstSubmitQcDate': '2024-06-28', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cecal Intubation Rate', 'timeFrame': 'Day 1', 'description': 'The proportion of procedures in which the cecum was reached.'}], 'secondaryOutcomes': [{'measure': 'Procedure Time', 'timeFrame': 'Day 1', 'description': 'Total procedure time and separated into cecal insertion time, time to reach ileum and withdrawal time.'}, {'measure': 'Ileum Intubation Rate', 'timeFrame': 'Day 1', 'description': 'Success rate of reaching the Ileum.'}, {'measure': 'Therapeutic Intervention Success Rate', 'timeFrame': 'Day 1', 'description': 'The ability to collect a biopsy or remove a polyp.'}, {'measure': 'Mean number of polyps per coloscopy and its detection rate', 'timeFrame': 'Day 1', 'description': 'Count of number of polyps seen during colonoscopy'}, {'measure': 'Mean number of adenomas and its detection rate', 'timeFrame': 'Day 14', 'description': 'Count of number of adenomas/sessile serrate lesions defined by pathology'}, {'measure': 'Mean number of sessile serrate lesions and its detection rate', 'timeFrame': 'Day 14', 'description': 'Count of number of adenomas/sessile serrate lesions defined by pathology'}, {'measure': 'Patient Satisfaction Survey', 'timeFrame': 'Day 14', 'description': 'During a follow-up phone call, the patient will be asked a yes or no question to rate their satisfaction of the procedure.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Colonic Polyp']}, 'descriptionModule': {'briefSummary': 'The goal of this observation study is to learn about the feasibility of a new colonoscope which provides the physician an extra-wide field of view during a screening colonoscopy. The main question this study aims to answer is can this new type of colonoscope locate polyps during clinical use in patients.\n\nPatients will undergo a routine colonoscopy for colorectal cancer or polyp surveillance and have one follow-up phone call up to 2 weeks of the colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults scheduled for screening colonoscopies, evaluation of a positive stool test or polyp surveillance colonoscopy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Screening for colorectal cancer at the age greater than or equal to 50 years, or evaluation of a positive stool test (i-FOBT) or polyp surveillance.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* ASA classification ≥3.\n* Age \\<18 years.\n* Known or suspicion of inflammatory bowel disease.\n* Known polyp(s) for polypectomy.\n* High risk for colorectal cancer, history of extensive polyposis, patients with known genetic disease.\n* Prior colorectal surgery.\n* Vulnerable subjects or subjects unable to follow the procedures of the investigation, e.g., due to language problems.\n* Unable or unwilling to undergo bowel cleansing for colonoscopy.\n* Female patients who are pregnant or nursing.\n* Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.'}, 'identificationModule': {'nctId': 'NCT06483503', 'acronym': 'EFOV', 'briefTitle': 'Extra Wide Field of View Lens Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pentax Medical'}, 'officialTitle': 'A Prospective Cohort Study Evaluating a Novel Colonoscope With a 230-degree Extra-wide Field of View Optics (EFOV)', 'orgStudyIdInfo': {'id': 'CA-PE-EFOV-2024-001 - V1.0'}}, 'armsInterventionsModule': {'interventions': [{'name': 'EFOV Colonoscope', 'type': 'DEVICE', 'description': 'Routine colonoscopy using the EFOV lens in the colonoscope.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'RKM 740 Interdisciplinary Care Clinic - Gastroenterology', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Horst Neuhaus, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RKM 740 Interdisciplinary Specialist Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pentax Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}