Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 5:49 PM
Study NCT ID:
NCT07377461
Status:
COMPLETED
Last Update Posted:
2026-02-09
First Post:
2026-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flexible and Navigable Suction Ureteral Access Sheath (FANS) vs Conventional Access Sheaths in RIRS: A Prospective Randomized Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}, {'id': 'D053040', 'term': 'Nephrolithiasis'}], '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': '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': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomized in a 1:1 ratio to one of two parallel intervention arms.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-05', 'studyFirstSubmitDate': '2026-01-07', 'studyFirstSubmitQcDate': '2026-01-26', 'lastUpdatePostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operative Time', 'timeFrame': 'During the surgical procedure', 'description': 'Operative time was defined as the duration from insertion of the first endoscopic instrument through the urethra to removal of the final instrument at the end of the procedure.'}], 'secondaryOutcomes': [{'measure': 'Intraoperative and Postoperative Complications', 'timeFrame': 'Perioperative period (Day of surgery through postoperative Day 30).', 'description': 'Intraoperative and postoperative complications were recorded and classified according to the Clavien-Dindo classification system.'}, {'measure': 'Stone-Free Rate', 'timeFrame': 'Two weeks after surgery', 'description': 'Stone-free status was defined as the absence of residual stone fragments greater than 2 mm on postoperative imaging.'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'From end of surgery until hospital discharge (typically 1-3 days).', 'description': 'Length of hospital stay was defined as the number of days from surgery to hospital discharge.'}, {'measure': 'Ureteral Wall Injury', 'timeFrame': 'During the surgical procedure', 'description': 'Ureteral wall injury was assessed intraoperatively and classified according to the Traxer-Thomas classification system.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Retrograde Intrarenal Surgery', 'Ureteral Access Sheath', 'Suction Ureteral Access Sheath', 'Flexible Tip Ureteral Access Sheath', 'RIRS', 'Operative Time', 'Endourology'], 'conditions': ['Kidney Stones', 'Nephrolithiasis']}, 'descriptionModule': {'briefSummary': 'Kidney stones located in the kidney are commonly treated using a minimally invasive procedure called retrograde intrarenal surgery (RIRS). During this procedure, a ureteral access sheath is often used to facilitate repeated access to the kidney, improve visualization, and allow irrigation fluid to drain.\n\nNewer access sheaths have been developed with flexible distal tips and built-in suction capabilities, which may help reduce operative time by improving visibility and removing stone fragments and irrigation fluid more efficiently.\n\nThis prospective randomized study compared a flexible and navigable suction ureteral access sheath with a conventional ureteral access sheath in adult patients undergoing RIRS for kidney stones measuring 10 mm or larger. Participants were randomly assigned to one of the two access sheath types.\n\nThe primary objective of the study was to evaluate whether the use of a suction-enabled access sheath reduces operative time. Secondary objectives included assessment of complications, length of hospital stay, stone-free rate, and need for additional interventions.', 'detailedDescription': 'This was a prospective, single-center, randomized controlled trial conducted at a tertiary referral endourology center. Adult patients (≥18 years) with renal stones measuring 10 mm or greater and scheduled to undergo retrograde intrarenal surgery (RIRS) under general anesthesia were eligible for inclusion.\n\nParticipants were randomized in a 1:1 ratio to undergo RIRS using either a flexible and navigable suction ureteral access sheath (FANS group) or a conventional ureteral access sheath (control group). Randomization was performed using a computer-generated sequence with allocation concealment via sealed opaque envelopes. Blinding of the operating surgeon was not feasible due to the nature of the devices used.\n\nAll procedures were performed by experienced endourologists using standardized surgical techniques. Flexible ureteroscopy was performed with a digital ureteroscope, and stone fragmentation was achieved using a Holmium:YAG laser in dusting mode. In the suction access sheath group, negative pressure suction was applied through the sheath according to manufacturer guidelines. Irrigation parameters were standardized across both study arms.\n\nThe primary outcome measure was operative time, defined as the interval from insertion of the first endoscopic instrument through the urethra to removal of the final instrument at the end of the procedure. Secondary outcome measures included intraoperative and postoperative complications (classified using the Clavien-Dindo system), ureteral wall injury, length of hospital stay, stone migration, and stone-free rate. Stone-free status was defined as the absence of residual fragments greater than 2 mm on postoperative imaging.\n\nPreoperative assessment included non-contrast computed tomography to evaluate stone size, location, and burden. Postoperative imaging was performed using kidney-ureter-bladder radiography or renal ultrasound approximately two weeks after surgery.\n\nThe study was approved by the Institutional Review Board of Barzilai University Medical Center, and all participants provided written informed consent prior to enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 18 years or older\n\nPresence of single or multiple renal stones measuring 10 mm or greater\n\nEligible for retrograde intrarenal surgery under general anesthesia\n\nAbility to provide written informed consent\n\nExclusion Criteria:\n\nPregnancy\n\nActive urinary tract infection at the time of surgery\n\nKnown bleeding disorders\n\nSolitary kidney\n\nAnatomical abnormalities of the urinary tract that could affect ureteroscopic access'}, 'identificationModule': {'nctId': 'NCT07377461', 'briefTitle': 'Flexible and Navigable Suction Ureteral Access Sheath (FANS) vs Conventional Access Sheaths in RIRS: A Prospective Randomized Study.', 'organization': {'class': 'OTHER', 'fullName': 'Barzilai Medical Center'}, 'officialTitle': 'Comparative Study of Access Sheaths With Flexible Tips and Suction Versus Conventional Access in Endourology: A Prospective Study', 'orgStudyIdInfo': {'id': '0069-24-BRZ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flexible and Navigable Suction Ureteral Access Sheath (FANS)', 'description': 'Participants underwent retrograde intrarenal surgery using a flexible and navigable ureteral access sheath with integrated suction capability.', 'interventionNames': ['Device: Flexible and Navigable Suction Ureteral Access Sheath (FANS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Ureteral Access Sheath', 'description': 'Participants underwent retrograde intrarenal surgery using a standard, non-suction ureteral access sheath.', 'interventionNames': ['Device: Conventional Ureteral Access Sheath']}], 'interventions': [{'name': 'Flexible and Navigable Suction Ureteral Access Sheath (FANS)', 'type': 'DEVICE', 'description': 'Use of a flexible distal-tip ureteral access sheath with integrated suction during retrograde intrarenal surgery to facilitate access, irrigation control, and fragment evacuation.', 'armGroupLabels': ['Flexible and Navigable Suction Ureteral Access Sheath (FANS)']}, {'name': 'Conventional Ureteral Access Sheath', 'type': 'DEVICE', 'description': 'Use of a standard ureteral access sheath without suction during retrograde intrarenal surgery.', 'armGroupLabels': ['Conventional Ureteral Access Sheath']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7830604', 'city': 'Ashkelon', 'country': 'Israel', 'facility': 'Barzilai University Medical Center', 'geoPoint': {'lat': 31.66926, 'lon': 34.57149}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barzilai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}