Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 8:54 PM
Study NCT ID:
NCT07463157
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FANS vs Standard Ureteral Access Sheath in fURS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 134}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-02-17', 'studyFirstSubmitQcDate': '2026-03-06', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiological stone-free rate (absence of residual fragments >=4 mm) assessed by low-dose non-contrast CT scan', 'timeFrame': 'Within 3 months (+/- 1 month) post-procedure', 'description': 'Proportion of participants classified as stone-free based on radiological evaluation using low-dose non-contrast computed tomography. Stone-free status is defined as absence of residual stone fragments \\>=4 mm.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Renal calculi', 'Kidney stones', 'Ureterorenoscopy', 'Laser lithotripsy', 'Ureteral access sheath', 'FANS device'], 'conditions': ['Renal Calculi']}, 'descriptionModule': {'briefSummary': 'This is a prospective, interventional single blinded, randomized, single-center study designed to compare the efficacy of a ureteral access sheath with integrated suction (FANS) versus a standard ureteral access sheath (UAS) in patients undergoing ureterorenoscopy and laser lithotripsy for renal stones. The hypothesis is that the use of the FANS device improves stone-free rates and reduces postoperative infectious complications compared to the standard sheath.', 'detailedDescription': 'Single-center, prospective, randomized, interventional, single blinded study. Participants with renal calculi undergoing ureterorenoscopy and laser lithotripsy will be randomized in a 1:1 ratio to receive either a standard ureteral access sheath (UAS) or the FANS (Flexible and Navigable Suction) sheath. Randomization will be stratified by stone characteristics, specifically stone density (≤1000 vs \\>1000 HU) and stone volume (\\<500 vs ≥500 mm³), as recorded on preoperative imaging, to reduce potential imbalance between study arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant is willing and able to provide written informed consent before any study-specific procedures are performed.\n2. Male or female, aged 18 years or older.\n3. Diagnosed with renal calculi ≥5 mm in diameter, confirmed by imaging, and eligible for fURS with laser lithotripsy according to European Association of Urology (EAU) guidelines.\n4. In stable general health and fit for elective endoscopic surgery under general anesthesia.\n5. Willing and able to comply with all study-related procedures, including follow-up imaging and clinical assessments.\n\n \\-\n\nExclusion Criteria:\n\n1. Solitary kidney (monorenal patients).\n2. Untreated positive urine culture or ongoing urinary tract infection not resolved with appropriate antibiotic therapy prior to surgery.\n3. Known anatomical abnormalities of the urinary tract that may interfere with ureteroscopic access or device placement (e.g., ureteral stricture, congenital malformations).\n4. Pregnancy or breastfeeding at the time of enrollment or planning pregnancy during the study period. In all female patients, a Gravindex test is performed on the day of admission; contraceptive measures are not required\n5. Concomitant ureteral stone\n6. Ureteral stenosis\n7. Known allergy or hypersensitivity to materials used in the investigational or control ureteral access sheath.\n8. Any severe comorbid condition (e.g., uncontrolled cardiovascular disease, severe coagulopathy, active malignancy) that in the opinion of the investigator would interfere with study participation or increase procedural risk.\n9. Any psychological, cognitive, or social condition that may limit the ability to provide informed consent or comply with follow-up procedures.'}, 'identificationModule': {'nctId': 'NCT07463157', 'acronym': 'CLEAR-URS', 'briefTitle': 'FANS vs Standard Ureteral Access Sheath in fURS', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Comparative Study on the Efficacy of the Ureteral Access Sheath With Integrated Suction FANS Versus the Standard Sheath in Patients With Renal Calculi Undergoing Ureterorenoscopy and Laser Lithotripsy: a Prospective, Randomized, Interventional, Single-center Study', 'orgStudyIdInfo': {'id': 'CLEAR-URS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard Ureteral Access Sheath (UAS)', 'description': 'Participants receive the standard ureteral access sheath during ureterorenoscopy and laser lithotripsy.', 'interventionNames': ['Device: Standard ureteral access sheath']}, {'type': 'EXPERIMENTAL', 'label': 'FANS Ureteral Access Sheath (Elephant-II)', 'description': 'Participants receive the Flexible and Navigable Suction (FANS) ureteral access sheath during ureterorenoscopy and laser lithotripsy.', 'interventionNames': ['Device: Flexible and Navigable Suction (FANS) Ureteral Access Sheath']}], 'interventions': [{'name': 'Standard ureteral access sheath', 'type': 'DEVICE', 'description': 'Participants undergo flexible ureterorenoscopy and laser lithotripsy using a standard ureteral access sheath according to institutional practice.', 'armGroupLabels': ['Standard Ureteral Access Sheath (UAS)']}, {'name': 'Flexible and Navigable Suction (FANS) Ureteral Access Sheath', 'type': 'DEVICE', 'description': 'The Flexible and Navigable Suction (FANS) ureteral access sheath (Elephant-II), which enables active suction during flexible ureterorenoscopy and laser lithotripsy.', 'armGroupLabels': ['FANS Ureteral Access Sheath (Elephant-II)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Luca LV Villa', 'role': 'CONTACT', 'email': 'villa.luca@hsr.it', 'phone': '0226439742'}, {'name': 'Concetta Cangemi', 'role': 'CONTACT', 'email': 'cangemi.concetta@hsr.it', 'phone': '0226435662'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Luca Villa', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}