Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT05646069
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2022-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Novel Disposable Flexible Ureteroscope for the Treatment of Renal Calculi
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}], 'ancestors': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2022-11-18', 'studyFirstSubmitQcDate': '2022-12-02', 'lastUpdatePostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scope performance', 'timeFrame': '0-1 day', 'description': 'Difference in scope performance grading by multiple blinded reviewers'}], 'secondaryOutcomes': [{'measure': 'Operating room outcomes', 'timeFrame': '0-1 day', 'description': 'The difference in operating room outcomes: basketing time'}, {'measure': 'Operating room outcomes', 'timeFrame': '0-1 day', 'description': 'The difference in operating room outcomes: scope setup time'}, {'measure': 'Operating room outcomes', 'timeFrame': '0-1 day', 'description': 'The difference in operating room outcomes: laser-use time'}, {'measure': 'Operating room outcomes', 'timeFrame': '0-1 day', 'description': 'The difference in operating room outcomes: operative time'}, {'measure': 'Operating room outcomes', 'timeFrame': '0-1 day', 'description': 'The difference in operating room outcomes: number of flexible ureteroscopes used'}, {'measure': 'Post-operative outcomes', 'timeFrame': '4-6 weeks', 'description': 'The difference in postoperative outcomes using a questionnaire: the patient has a UTI'}, {'measure': 'Post-operative outcomes', 'timeFrame': '4-6 weeks', 'description': 'The difference in postoperative outcomes using a questionnaire: the patient is stone-free'}, {'measure': 'Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (resolution)', 'timeFrame': '4-6 weeks', 'description': 'Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5)'}, {'measure': 'Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (color)', 'timeFrame': '4-6 weeks', 'description': 'Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5)'}, {'measure': 'Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: color interference', 'timeFrame': '4-6 weeks', 'description': 'Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5)'}, {'measure': 'Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: laser interference', 'timeFrame': '4-6 weeks', 'description': 'Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5)'}, {'measure': 'Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: field of view', 'timeFrame': '4-6 weeks', 'description': 'Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5)'}, {'measure': 'Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: overall impression', 'timeFrame': '4-6 weeks', 'description': 'Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['UTI', 'Stone, Kidney']}, 'referencesModule': {'references': [{'pmid': '39937281', 'type': 'DERIVED', 'citation': 'Wong C, Xu P, Dean N, Assmus M, McDonald A, Agarwal D, Ali S, Abedi G, Margolin E, Medairos R, Nottingham C, Krambeck A. A prospective survey evaluating the visual quality of KARL STORZ fiberoptic, digital, and disposable flexible ureteroscopes. World J Urol. 2025 Feb 12;43(1):119. doi: 10.1007/s00345-025-05502-x.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to provide an evaluation of currently available disposable flexible ureteroscopes in real-world conditions. Due to high re-processing costs associated with re-usable flexible ureteroscopes, there has been a demand for Urologic device manufacturers to provide single-use flexible ureteroscopes.', 'detailedDescription': 'Patients randomized to the experimental group will receive flexible ureteroscopy with the Storz Flex-XC1 disposable flexible ureteroscope.\n\nData will be collected and stored electronically in REDCap. Quality assurance steps will include testing of the database, including any potential data calculated by command functions within REDCap\n\nScope performance survey will be administered with REDcap.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and Females 18-89 undergoing ureteroscopy for laser treatment of renal calculi\n* Willing to sign the Informed Consent Form\n* Able to read, understand, and complete patient questionnaires, pain texts, and medication diary.\n\nExclusion Criteria:\n\n* Patients having a concomitant procedure along with ureteroscopy (example: contralateral PCNL)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05646069', 'briefTitle': 'Evaluation of Novel Disposable Flexible Ureteroscope for the Treatment of Renal Calculi', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Evaluation of Novel Disposable Flexible Ureteroscope for the Treatment of Renal Calculi', 'orgStudyIdInfo': {'id': 'STU00217933'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Storz Flex-XC1 disposable flexible ureteroscope', 'description': 'A patient is randomized to the experimental arm using the Storz Flex-XC1 disposable flexible ureteroscope.', 'interventionNames': ['Device: Storz Flex-XC1 Disposable Flexible Ureteroscope']}, {'type': 'NO_INTERVENTION', 'label': 'Analogue scope', 'description': 'A patient is not randomized to the experimental arm using the Storz Flex-XC1 disposable flexible ureteroscope.'}, {'type': 'EXPERIMENTAL', 'label': 'Digital ureteroscope', 'description': 'A patient is randomized to the experimental arm using a Digital ureteroscope.', 'interventionNames': ['Device: Storz Flexible Digital Ureteroscope']}], 'interventions': [{'name': 'Storz Flex-XC1 Disposable Flexible Ureteroscope', 'type': 'DEVICE', 'description': 'Patients will receive flexible ureteroscopy with the Storz Flex-XC1 disposable flexible ureteroscope.', 'armGroupLabels': ['Storz Flex-XC1 disposable flexible ureteroscope']}, {'name': 'Storz Flexible Digital Ureteroscope', 'type': 'DEVICE', 'description': 'Patients will receive flexible ureteroscopy with the Storz flexible Digital ureteroscope.', 'armGroupLabels': ['Digital ureteroscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Urology', 'investigatorFullName': 'Amy Krambeck', 'investigatorAffiliation': 'Northwestern University'}}}}