Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2026-02-25 @ 5:53 PM
Study NCT ID:
NCT03331705
Status:
UNKNOWN
Last Update Posted:
2017-11-06
First Post:
2017-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Uro-C Cystoscope for Use in Diagnostic Cystoscopy Procedures
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-09-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-02', 'studyFirstSubmitDate': '2017-10-26', 'studyFirstSubmitQcDate': '2017-11-02', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the utility and performance of the cystoscope by the physician', 'timeFrame': 'during the procedure', 'description': 'Ranking with Likert Scale on ease of advancement, visibility of tissue and structures, and removal of the device'}], 'secondaryOutcomes': [{'measure': 'Patient tolerance of the procedure', 'timeFrame': 'during and within 5 days after the procedure', 'description': 'Assess level of discomfort or adverse event associated with the procedure by the subject using the Likert Scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bladder Tumor']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter, single-arm, open-label clinical usability study in subjects who are candidates for office diagnostic cystoscopy. The primary objective of this initial device assessment is to evaluate the performance of a new cystoscope for direct visualization of the urethra and bladder.', 'detailedDescription': 'A new cystoscope has been designed for female diagnostic cystoscopy, with a focus on promoting patient comfort, tolerability and safety while improving office efficiency. The cystoscope, named the Uro-C, is light-weight, ergonomic, handheld, battery-operated portable system that integrates a disposable cannula with a reusable handle that contains video electronics, is wireless capable, and has a liquid crystal display (LCD) monitor. Cystoscopy with the new system is performed in a standard manner to cystoscopy with currently available endoscopes, so risks are no different than when currently available endoscopes are used.\n\nThis is a prospective, multi-center, single-arm, open-label clinical usability study in subjects who are candidates for office diagnostic cystoscopy. The primary objective of this initial device assessment is to evaluate the performance of the cystoscope for direct visualization of the urethra and bladder.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Females requiring a diagnostic cystoscopic procedure', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Otherwise healthy adult (18 years of age or older) women presenting for cystoscopy for diagnostic purposes; and\n2. Ambulatory and able to undergo routine cystoscopy in the lithotomy position.\n\nExclusion Criteria:\n\n1. History of prior bladder/urethral surgery other than TURBT; or\n2. History of interstitial cystitis; or\n3. Presence of urinary tract infection (UTI); or\n4. Gross hematuria; or\n5. History of pelvic radiation therapy; or\n6. Procidentia; or\n7. Unable to read, understand, and/or provide a ranking of pain level during the procedure; or\n8. Unable or unwilling to provide consent to participation in the study.'}, 'identificationModule': {'nctId': 'NCT03331705', 'briefTitle': 'Assessment of the Uro-C Cystoscope for Use in Diagnostic Cystoscopy Procedures', 'organization': {'class': 'INDUSTRY', 'fullName': 'UroSee Corporation'}, 'officialTitle': 'Evaluation of the Performance of a Disposable Cystoscope System for Direct Visualization of the Urethra and Bladder', 'orgStudyIdInfo': {'id': '16-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Use of new cystoscope', 'description': 'Patients in which the cystoscope is used.', 'interventionNames': ['Device: Uro-C (Use of new cystoscope)']}], 'interventions': [{'name': 'Uro-C (Use of new cystoscope)', 'type': 'DEVICE', 'description': 'Diagnostic cystoscopic procedure of the urethra and bladder', 'armGroupLabels': ['Use of new cystoscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vijay Goli, MD', 'role': 'CONTACT', 'phone': '702-233-0727'}, {'name': 'Marian Bertola, RN', 'role': 'CONTACT', 'phone': '702 385 4343'}], 'facility': 'Las Vegas Urology', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}], 'centralContacts': [{'name': 'Thomas Lawson, PhD', 'role': 'CONTACT', 'email': 'thom@urosee.com', 'phone': '510 206 1794'}, {'name': 'Bela Denes, MD', 'role': 'CONTACT', 'email': 'bdenes@urosee.com', 'phone': '949 378 0268'}], 'overallOfficials': [{'name': 'Bela Denes, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UroSee Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UroSee Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}