Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-30 @ 3:36 PM
Study NCT ID:
NCT06684756
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2024-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Vacuum-Assisted and Conventional Ureteral Access Sheath in Retrograde Intrarenal Surgery
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2024-11-08', 'studyFirstSubmitQcDate': '2024-11-09', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stone free rates', 'timeFrame': 'Stone-free status will be checked by performing a non-contrast abdominal CT scan 1 month after the operation.', 'description': 'Presence/absence of residual fragments in postoperative imaging, if any, diameter of longest axis in mm.'}], 'secondaryOutcomes': [{'measure': 'Complication rates', 'timeFrame': 'Peroperative complication rates will be determined during the operation, and postoperative complications will be re-evaluated during hospitalization before discharge or in the first month after discharge.', 'description': 'Peroperative and postoperative complication rates, whether UAS related or not'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['kidney stone', 'retrograde intrarenal surgery', 'ureteral access sheath', 'vacuum assisted'], 'conditions': ['Kidney Calculi', 'Kidney Stones']}, 'referencesModule': {'references': [{'pmid': '37347309', 'type': 'BACKGROUND', 'citation': 'Wang D, Xu Y, Liu Z, Liang J, Lai D, Guan W, Xu G. Using vacuum-assisted ureteral access sheath in the treatment of complex steinstrasse. Urolithiasis. 2023 Jun 22;51(1):89. doi: 10.1007/s00240-023-01462-2.'}, {'pmid': '37821778', 'type': 'BACKGROUND', 'citation': 'Zhang Z, Xie T, Li F, Wang X, Liu F, Jiang B, Zou X, Zhang G, Yuan Y, Xiao R, Wu G, Qian B. Comparison of traditional and novel tip-flexible suctioning ureteral access sheath combined with flexible ureteroscope to treat unilateral renal calculi. World J Urol. 2023 Dec;41(12):3619-3627. doi: 10.1007/s00345-023-04648-w. Epub 2023 Oct 11.'}, {'pmid': '38024505', 'type': 'BACKGROUND', 'citation': 'Nao T, Iga R, Yoshimura R, Kurano Y, Yamamoto S, Tamura K. A new method for effective use of the ClearPetra ureteral access sheath for a giant ureteral stone. Urol Case Rep. 2023 Oct 23;51:102599. doi: 10.1016/j.eucr.2023.102599. eCollection 2023 Nov.'}, {'pmid': '38789313', 'type': 'RESULT', 'citation': 'Gauhar V, Traxer O, Castellani D, Sietz C, Chew BH, Fong KY, Hamri SB, Gokce MI, Gadzhiev N, Galosi AB, Yuen SKK, El Hajj A, Ko R, Zawadzki M, Sridharan V, Lakmichi MA, Corrales M, Malkhasyan V, Ragoori D, Soebhali B, Tan K, Chai CA, Tursunkulov AN, Tanidir Y, Persaud S, Elshazly M, Kamal W, Tefik T, Shrestha A, Tiong HC, Somani BK. Could Use of a Flexible and Navigable Suction Ureteral Access Sheath Be a Potential Game-changer in Retrograde Intrarenal Surgery? Outcomes at 30 Days from a Large, Prospective, Multicenter, Real-world Study by the European Association of Urology Urolithiasis Section. Eur Urol Focus. 2024 Dec;10(6):975-982. doi: 10.1016/j.euf.2024.05.010. Epub 2024 May 24.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare the efficacy and safety, the ratio of stone-free rates, and complications of two types of access sheaths used in retrograde intrarenal surgery to treat upper urothelial stones. The access sheath types are those with vacuum aspiration and the conventional ones.', 'detailedDescription': 'The use of ureteral access sheath (UAS) during Retrograde Intrarenal Surgery (RIRS) has been proven effective and reliable in recent years, and publications indicate that it reduces stone-free rates (SFR). Their use is also recommended in the European Urology Guidelines because it improves image quality, reduces intrarenal pressure, and shortens the operation time. For this reason, it has been routinely used in many RIRS cases. In cases where non-vacuum-assisted UAS is used, fragments during stone fragmentation remain in the kidney, and since it is not possible to remove the stones simultaneously, the image may be distorted, and the operation duration may be prolonged. All these may pave the way for postoperative infectious complications. In addition to non-vacuum-assisted UAS, new UASs with flexible ends and vacuum-assisted aspiration have been introduced in the last few years (ClearPetra). Thanks to the aspiration connected to the system, stone fragments can be removed from the body with negative pressure during stone fragmentation. Continuous circulation prevents bleeding during fragmentation and blurring of the visual field due to stone fragments. In addition, since the stone fragments pass through the edges of the sheath without breaking and are removed, a perfect field of view can be provided. Unlike the classical UAS, the tip is flexible, allowing for the safe removal of lower pole stones. Many studies in the literature compare the success and complications of RIRS in cases where conventional UAS was used and not used. In addition, there are publications related to using the newly introduced aspiration access sheath in percutaneous nephrolithotomy. In retrospective publications on using this UAS in RIRS, it has been shown that stone-free rates, operation time, hemoglobin loss, and postoperative infective complications are more successful on the 1st and 30th postoperative days compared to cases where non-vacuum-assisted UAS was used. There is no randomized controlled prospective publication on this subject. This study aims to compare the complications and stone-free rates of RIRS cases where non-vacuum-assisted UAS and new vacuum-assisted UAS were used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age\n* Patients below 85 years of age\n* Patients with 11-13 FR conventional/vacuum-assisted ureteral access sheath (UAS) during retrograde intrarenal surgery\n\nExclusion Criteria:\n\n* Patients with non-sterile preoperative urine culture\n* Patients with renal anatomic anomalies\n* Patients with a solitary (single) kidney\n* Patients with insufficient data\n* Patients under the age of 18, above the age of 85\n* Patients without an UAS during RIRS\n* Patients without 11-13Fr UAS during RIRS'}, 'identificationModule': {'nctId': 'NCT06684756', 'briefTitle': 'Comparison of Vacuum-Assisted and Conventional Ureteral Access Sheath in Retrograde Intrarenal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Namik Kemal University'}, 'officialTitle': 'The Comparison of the Efficacy and Safety of Vacuum-Assisted and Conventional Ureteral Access Sheath in Retrograde Intrarenal Surgery: A Randomized Controlled Prospective Multicenter Study', 'orgStudyIdInfo': {'id': '2024.288.10.16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients with conventional UAS being used in their RIRS operations', 'description': 'The patient population will be selected from cases determined by randomization and used with UAS without an aspiration (conventional) during RIRS.', 'interventionNames': ['Procedure: Retrograde intrarenal surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Patients with vacuum assisted UAS being used in their RIRS operations', 'description': 'The patient population will be selected from cases determined by randomization and used with UAS with an aspiration and flexible tip, different from the conventional one during RIRS.', 'interventionNames': ['Procedure: Retrograde intrarenal surgery']}], 'interventions': [{'name': 'Retrograde intrarenal surgery', 'type': 'PROCEDURE', 'description': 'Flexible optic devices and lasers fragment kidney stones during this operation. In this surgery, an ureteral access sheath is recommended to be used.', 'armGroupLabels': ['Patients with conventional UAS being used in their RIRS operations', 'Patients with vacuum assisted UAS being used in their RIRS operations']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tekirdağ', 'state': 'Turkey', 'country': 'Turkey (Türkiye)', 'facility': 'Tekirdag Namık Kemal University', 'geoPoint': {'lat': 40.9781, 'lon': 27.51101}}], 'overallOfficials': [{'name': 'Cenk M. Yazici, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Namik Kemal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Namik Kemal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mehmet Fatih Şahin', 'investigatorAffiliation': 'Namik Kemal University'}}}}