Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-01 @ 6:43 PM
Study NCT ID:
NCT05952635
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2023-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tip Bendable Suction Ureteral Access Sheath vs. Traditional Ureteral Access Sheath in Retrograde Intrarenal Stone 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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-22', 'studyFirstSubmitDate': '2023-06-17', 'studyFirstSubmitQcDate': '2023-07-17', 'lastUpdatePostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immediate stone-free rate', 'timeFrame': 'Postoperative day 1', 'description': 'No residual stone, or no stone fragments larger than 2 mm on KUB and ultrasound at postoperative day 1 are defined as stone free.'}], 'secondaryOutcomes': [{'measure': 'Stone-free rate at 3 months', 'timeFrame': 'Postoperative 3 month', 'description': 'No residual stone, or no stone fragments larger than 2 mm on CT scan at postoperative 3 month are defined as stone free.'}, {'measure': 'Duration of hospital stay', 'timeFrame': 'From date of operation until the date of discharge, assessed up to 2 weeks.'}, {'measure': 'Further interventions received up to 3 months post randomization', 'timeFrame': 'Postoperative 3 month'}, {'measure': 'Complications up to 3 months post randomization', 'timeFrame': 'Postoperative 3 month'}, {'measure': 'Change of Quality of life Score (prior to surgery and at month 3 after randomization)', 'timeFrame': 'Postoperative 3 month'}, {'measure': 'Operative time', 'timeFrame': 'From start of operation until the end of operation, assessed up to 2 weeks.', 'description': 'The duration from the insertion of the endoscope into the urethra to the completion of stent placement.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney stone', 'Flexible ureteroscopy', 'Ureteral access sheath'], 'conditions': ['Kidney Stone']}, 'referencesModule': {'references': [{'pmid': '39070176', 'type': 'DERIVED', 'citation': 'Zhu W, Liu S, Cao J, Wang H, Liang H, Jiang K, Cui Y, Chai CA, Sahinler EB, Aquino A, Mazzon G, Zhong W, Zhao Z, Zhang L, Ding J, Wang Q, Wang Y, Chen KW, Liu Y, Choong S, Sarica K, Zeng G. Tip bendable suction ureteral access sheath versus traditional sheath in retrograde intrarenal stone surgery: an international multicentre, randomized, parallel group, superiority study. EClinicalMedicine. 2024 Jul 5;74:102724. doi: 10.1016/j.eclinm.2024.102724. eCollection 2024 Aug.'}]}, 'descriptionModule': {'briefSummary': 'Nephrolithiasis is the most common chronic kidney condition and affecting approximately one in every 10-17 people in the world\\[1,2\\]. Flexible ureteroscopy (f-URS) has become one of the most common treatments for ureteral and renal stones with minimal complications. The development of ureteral access sheath (UAS) is a significant advance in flexible ureteroscopic management of urinary stones. The UAS has two major advantages: 1) facilitating multiple entries into the renal collecting system without causing recurrent trauma to the ureter and permit expeditious basketing of multiple stone fragments, 2) improving the irrigation with better fluid outflow, thereby reducing the renal pelvic pressure (RPP) and risk of infectious complications.\n\nThe tip bendable suction ureteral access sheath (S-UAS) is a novel UAS that has good flexibility and deformability at the tip, which can passively bend (bend \\>90°) with the bending of f-URS and can connect to a vacuum suction device. Preliminary study showed that S-UAS can follow f-URS to cross the UPJ and into the renal pelvis and calices. S-UAS close to the stone can achieve complete stone-free status in RIRS. However, further clinical studies and comparisons with available techniques are required. This prospective, single-blinded, single-center, randomized control trial will evaluate the stone free rates, operative time, postoperative complications following RIRS with S-UAS. To the best of our knowledge, this is the first study to compare the clinical benefits of RIRS with S-UAS and traditional UAS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged ≥ 18 years;\n* American Society of Anesthesiology score 1-3;\n* Upper urinary stone (kidney stone or upper ureteral stone) diameter of ≤ 3 cm confirmed by CT;\n* Capable of giving written informed consent, which includes adherence with the requirements of the trial.\n\nExclusion Criteria:\n\n* Patients with abnormal urinary tract anatomy (such as horseshoe kidney or ileal conduit);\n* Patients with uncontrolled UTI;\n* Patients with health or other factors that are absolute contraindications to RIRS;\n* Patients unable to understand or complete trial documentation.'}, 'identificationModule': {'nctId': 'NCT05952635', 'briefTitle': 'Tip Bendable Suction Ureteral Access Sheath vs. Traditional Ureteral Access Sheath in Retrograde Intrarenal Stone Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'Tip Bendable Suction Ureteral Access Sheath vs. Traditional Ureteral Access Sheath in Retrograde Intrarenal Stone Surgery (RIRS): Study Protocol of a Multicentre, Prospective, Single-blinded, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MRER2023-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tip bendable suction ureteral access sheath (S-UAS) group', 'description': 'Patients will use S-UAS during flexible ureteroscopy.', 'interventionNames': ['Procedure: Tip bendable suction ureteral access sheath']}, {'type': 'NO_INTERVENTION', 'label': 'Traditional ureteral access sheath group', 'description': 'Patients will use traditional UAS during flexible ureteroscopy.'}], 'interventions': [{'name': 'Tip bendable suction ureteral access sheath', 'type': 'PROCEDURE', 'description': 'Patient use tip bendable suction ureteral access sheath during flexible ureteroscopy to see if flexible ureteroscopy with S-UAS offers the better treatment outcomes in terms of clinical effectiveness and post-operative complications.', 'armGroupLabels': ['Tip bendable suction ureteral access sheath (S-UAS) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510230', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Department of Urology, The First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}, {'name': 'Xinchang County Hospital of Traditional Chinese Medicine', 'class': 'UNKNOWN'}, {'name': 'Prof. Dr. Ilhan Varank Education and Training Hospital', 'class': 'UNKNOWN'}, {'name': 'Jose R. Reyes Memorial Medical Center', 'class': 'OTHER_GOV'}, {'name': "Guizhou Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'University of Malaya', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice president', 'investigatorFullName': 'Guohua Zeng', 'investigatorAffiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}}}}