Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-01-22 @ 5:42 PM
Study NCT ID:
NCT07225933
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-07
First Post:
2025-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D007669', 'term': 'Kidney Calculi'}], 'ancestors': [{'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': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-06', 'studyFirstSubmitDate': '2025-11-05', 'studyFirstSubmitQcDate': '2025-11-06', 'lastUpdatePostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stone free Status', 'timeFrame': 'Post-Operative up to 90 Days', 'description': 'Completed by reviewing any available standard of care post-procedure imaging'}, {'measure': 'Intra- & Post-Operative Complications', 'timeFrame': 'Intra- & Post-Operative up to 90 Days', 'description': 'Completed by reviewing data available for intra- and post-op complications'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['SURE', 'FANS'], 'conditions': ['Urolithiasis', 'Kidney Stone', 'Kidney Stones']}, 'descriptionModule': {'briefSummary': 'This is a retrospective, multi-center collaboration to assess real-world outcomes of a novel steerable aspiration system, the CVAC® System ("CVAC"), and flexible and navigable suction ureteral access sheath (FANS) for the treatment of urinary stones.', 'detailedDescription': 'The objective of this study is observation of the safety and efficacy of subjects who underwent SURE procedure using the CVAC System or FANS for the removal of kidney stones in candidates for URS with laser lithotripsy. Efficacy will be observed by reviewing stone free status on standard of care post-procedure imaging. Safety will be observed by reviewing procedural information and if subjects had urologic events leading to Emergency Department (ED) visits, hospitalization, or retreatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects that are 18 or older that underwent the SURE procedure with the CVAC System or fURS with FANS in the retrospective cohort', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects that had SURE procedure with CVAC System performed in the retrospective cohort\n* Subjects that had flexible URS (fURS) procedure with FANS performed in the retrospective cohort\n\nExclusion Criteria:\n\n* For planned SURE procedures, the inability for CVAC to gain access required for treatment of kidney stones'}, 'identificationModule': {'nctId': 'NCT07225933', 'acronym': 'REASON', 'briefTitle': 'A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Calyxo, Inc.'}, 'officialTitle': 'A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System', 'orgStudyIdInfo': {'id': 'CP00005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC System', 'description': 'The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).', 'interventionNames': ['Device: CVAC® SYSTEM']}, {'label': 'FLEXIBLE AND NAVIGATIONAL URETERAL ACCESS SHEATH (FANS) IN FLEXIBLE URETEROSCOPY (FURS)', 'description': 'FANS is designed to incorporate suction to facilitate stone fragment removal through its lumen and is used with a separate ureteroscope. FANS is fitted with a Y connector with a pressure control vent and connects to a standard vacuum device. A separate ureteroscope provides direct visualization and irrigation and a separate specimen collector captures stone debris.', 'interventionNames': ['Device: FLEXIBLE AND NAVIGATIONAL URETERAL ACCESS SHEATH (FANS) IN FLEXIBLE URETEROSCOPY (FURS)']}], 'interventions': [{'name': 'CVAC® SYSTEM', 'type': 'DEVICE', 'otherNames': ['SURE', 'CVAC'], 'description': 'The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).', 'armGroupLabels': ['Steerable Ureteroscopic Renal Evacuation (SURE) with CVAC System']}, {'name': 'FLEXIBLE AND NAVIGATIONAL URETERAL ACCESS SHEATH (FANS) IN FLEXIBLE URETEROSCOPY (FURS)', 'type': 'DEVICE', 'otherNames': ['FANS', 'fURS'], 'description': 'FANS is designed to incorporate suction to facilitate stone fragment removal through its lumen and is used with a separate ureteroscope. FANS is fitted with a Y connector with a pressure control vent and connects to a standard vacuum device. A separate ureteroscope provides direct visualization and irrigation and a separate specimen collector captures stone debris.', 'armGroupLabels': ['FLEXIBLE AND NAVIGATIONAL URETERAL ACCESS SHEATH (FANS) IN FLEXIBLE URETEROSCOPY (FURS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093-0934', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego (UCSD)', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Roger Sur, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Calyxo, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of California, San Diego', 'class': 'OTHER'}, {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, {'name': 'OhioHealth Research Institute', 'class': 'UNKNOWN'}, {'name': 'Feinstein Institute for Medical Research', 'class': 'OTHER'}, {'name': 'Summit Medical', 'class': 'UNKNOWN'}, {'name': 'Western New York Urology Associates', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}