Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 11:49 PM
Study NCT ID:
NCT04519294
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-22
First Post:
2020-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Laser Lithotripsy With and Without Steerable Ureteroscopic Renal Evacuation (SURE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-10'}], 'estimatedResultsFirstSubmitDate': '2025-12-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}, {'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D052878', 'term': 'Urolithiasis'}], 'ancestors': [{'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': '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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 162}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2020-08-17', 'studyFirstSubmitQcDate': '2020-08-17', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SFR', 'timeFrame': '30 days', 'description': 'Stone Free Rate'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Kidney Stone', 'Renal Stone', 'Urolithiasis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the effects, good and/or bad, of a treatment for removing kidney stones called the SURE procedure for stone evacuation to the standard treatment using a basket for stone removal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Candidate for ureteroscopy with laser lithotripsy;\n* Presence of renal stone(s);\n* Be willing and able to return for all study-related follow up procedures; and,\n* Have been informed of the nature of the study, agreeing to its requirements, and have signed the IRB approved informed consent.\n\nExclusion Criteria:\n\n* BMI \\> 45;\n* Significant comorbidities;\n* Bladder, ureteral or kidney abnormalities;\n* Pregnant individuals; or\n* Unable to meet the treatment and follow up protocol requirements.'}, 'identificationModule': {'nctId': 'NCT04519294', 'briefTitle': 'Comparison of Laser Lithotripsy With and Without Steerable Ureteroscopic Renal Evacuation (SURE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Calyxo, Inc.'}, 'officialTitle': 'A Prospective, Randomized Study to Evaluate the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation(SURE)Using the CVAC™ Aspiration System Compared to Basketing for the Removal of Renal Calculi Following Laser Lithotripsy', 'orgStudyIdInfo': {'id': 'CP00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SURE', 'interventionNames': ['Device: SURE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Ureteroscopy (Basketing)', 'interventionNames': ['Device: Standard Ureteroscopy (Basketing)']}], 'interventions': [{'name': 'SURE', 'type': 'DEVICE', 'description': 'The SURE stone evacuation procedure is a technique intended to more easily and completely remove a kidney stone during a kidney stone treatment. The urologist first uses a laser to break the kidney stone into small pieces. Then with the SURE procedure, the pieces are gently vacuumed out of the kidney instead of retrieving the pieces one-by-one with a basket or leaving them to pass naturally in the urine. Basketing is allowed and might be used with the SURE procedure, if needed to remove some small stones.', 'armGroupLabels': ['SURE']}, {'name': 'Standard Ureteroscopy (Basketing)', 'type': 'DEVICE', 'description': 'This is a treatment in which the urologist uses a laser to break a kidney stone into small pieces and then uses a tool called a basket to retrieve the pieces one at a time.', 'armGroupLabels': ['Standard Ureteroscopy (Basketing)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Institute of Urology', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '08043', 'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'facility': 'New Jersey Urology', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical College', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '29650', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '78654', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Urology Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78712', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Dell Medical School, The University of Texas at Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '23462', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Urology of Virginia', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Calyxo, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}