Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-04 @ 2:56 AM
Study NCT ID:
NCT06889051
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-21
First Post:
2025-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Flexible & Navigable Suction Ureteral Access Sheath vs. Antegrade Suction in Retrograde Flexible Ureteroscopy for Lower Calyceal Stones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D052878', 'term': 'Urolithiasis'}], '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': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open-label trial with no masking, as both the surgeon and patient will be aware of the assigned intervention.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized controlled trial comparing two different suction techniques during retrograde flexible ureteroscopy (FURS) for lower calyceal renal stones. Participants will be assigned to one of two groups:\n\n* Group A (Intervention Group) - flexible ureteroscopy (FURS) with Flexible \\& Navigable Suction Ureteral Access Sheath (FANS)\n* Group B (Control Group) - flexible ureteroscopy (FURS) with Antegrade Suction via percutaneous nephrostomy.\n\nThe study will assess stone-free rates (SFR), operative time, and complications.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-15', 'studyFirstSubmitDate': '2025-03-15', 'studyFirstSubmitQcDate': '2025-03-15', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stone-Free Rate (SFR)', 'timeFrame': '1 Month Postoperative', 'description': 'The stone-free rate (SFR) will be assessed one month postoperatively using non-contrast computed tomography (NCCT) to determine the presence or absence of residual stone fragments ≥4 mm. A higher SFR indicates better effectiveness of the intervention.'}], 'secondaryOutcomes': [{'measure': 'Operative Time', 'timeFrame': 'During Surgery', 'description': 'The total operative time will be recorded from the initial endoscopic access to procedure completion. This includes access sheath insertion, ureteroscopy, lithotripsy, and final stone evacuation. A shorter operative time is indicative of a more efficient technique.'}, {'measure': 'Intraoperative Bleeding Requiring Intervention', 'timeFrame': 'During Surgery', 'description': 'The incidence of ureteral injuries, including mucosal damage, perforation, or full-thickness injury, will be documented. The severity will be graded based on endoscopic findings and clinical impact.'}, {'measure': 'Ureteral Injury', 'timeFrame': 'During Surgery', 'description': 'The incidence of ureteral injuries, including mucosal damage, perforation, or full-thickness injury, will be documented. The severity will be graded based on endoscopic findings and clinical impact.'}, {'measure': 'Postoperative Hematuria', 'timeFrame': 'Within 7 Days Postoperative', 'description': 'The presence of postoperative hematuria (macroscopic bleeding) will be assessed. It will be classified as mild (self-limited), moderate (requiring irrigation), or severe (requiring intervention such as transfusion or embolization).'}, {'measure': 'Postoperative Urosepsis', 'timeFrame': 'Within 7 Days Postoperative', 'description': 'The incidence of postoperative urosepsis, defined as systemic inflammatory response syndrome (SIRS) with a positive urine culture and clinical deterioration requiring IV antibiotics or ICU admission, will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Flexible Ureteroscopy (FURS)', 'Ureteral Access Sheath (UAS)', 'Suction Ureteral Access Sheath (FANS)', 'Antegrade Suction', 'Percutaneous Nephrostomy (PCN)', 'Laser Lithotripsy'], 'conditions': ['Nephrolithiasis', 'Urolithiasis', 'Endourology']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aims to compare the efficacy and safety of two suction techniques during retrograde flexible ureteroscopy (FURS) for lower calyceal renal stones measuring 1.5-2 cm. The study evaluates Flexible \\& Navigable Suction Ureteral Access Sheath (FANS) versus Antegrade Suction (via percutaneous access) in improving stone-free rates (SFR), reducing operative time, and minimizing complications such as bleeding, ureteral injury, and infection. A total of 120 adult patients will be randomized into two groups, undergoing either flexible ureteroscopy (FURS) with Flexible \\& Navigable Suction Ureteral Access Sheath (FANS) or flexible ureteroscopy (FURS) with antegrade suction, at Banha University Faculty of Medicine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (≥18 years old)\n* Patients diagnosed with renal stones (1.5-2 cm) confirmed by non-contrast computed tomography (NCCT)\n* Patients undergoing flexible ureteroscopy (FURS) as the primary treatment approach\n* Patients with no active urinary tract infection (UTI) at baseline\n* Patients who provide written informed consent\n\nExclusion Criteria:\n\n* Patients with anatomical anomalies (e.g., horseshoe kidney, PUJ obstruction)\n* Patients with a single functioning kidney\n* Pregnant women\n* Patients with a history of urological malignancy\n* Patients with active bleeding disorders or those on anticoagulant therapy that cannot be safely discontinued\n* Patients at high risk for anesthesia'}, 'identificationModule': {'nctId': 'NCT06889051', 'briefTitle': 'Comparison of Flexible & Navigable Suction Ureteral Access Sheath vs. Antegrade Suction in Retrograde Flexible Ureteroscopy for Lower Calyceal Stones', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Comparison Study Between Using Retrograde Flexible Ureteroscopy With Flexible & Navigable Suction Ureteral Access Sheath Versus Retrograde Flexible Ureteroscopy With Antegrade Suction in Lower Calyceal Stone: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MD-290-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flexible & Navigable Suction Ureteral Access Sheath (FANS) Group', 'description': 'Patients in this group will undergo retrograde flexible ureteroscopy (FURS) with the Flexible \\& Navigable Suction Ureteral Access Sheath (FANS). The FANS facilitates continuous suctioning, improving stone fragment evacuation, reducing intrarenal pressure, and optimizing stone-free rates (SFR).', 'interventionNames': ['Procedure: Flexible & Navigable Suction Ureteral Access Sheath (FANS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Antegrade Suction with Flexible Ureteroscopy (FURS) Group', 'description': 'Patients in this group will undergo retrograde flexible ureteroscopy (FURS) with antegrade suction, using a percutaneous nephrostomy (PCN) access for suctioning from the kidney during the procedure. This method aims to enhance stone fragment clearance and reduce intrarenal pressure without using a ureteral access sheath.', 'interventionNames': ['Procedure: Antegrade Suction via Percutaneous Nephrostomy']}], 'interventions': [{'name': 'Flexible & Navigable Suction Ureteral Access Sheath (FANS)', 'type': 'PROCEDURE', 'description': 'The Flexible \\& Navigable Suction Ureteral Access Sheath (FANS) is used during retrograde flexible ureteroscopy (FURS) for renal stones (1.5-2 cm). It allows continuous active suctioning, improving stone fragment evacuation, reducing operative time, lowering intrarenal pressure, and optimizing stone-free rates (SFR). The procedure involves inserting the Navigator 10F, 55 cm YIGAOMED FANS over a guidewire, followed by flexible ureteroscopy with PUSEN® 9.2 Fr ureteroscope and laser lithotripsy using Holmium Laser (JenaSurgical® MultiPulse HoPLUS™ 150W).', 'armGroupLabels': ['Flexible & Navigable Suction Ureteral Access Sheath (FANS) Group']}, {'name': 'Antegrade Suction via Percutaneous Nephrostomy', 'type': 'PROCEDURE', 'description': 'This technique involves antegrade suction from the kidney during flexible ureteroscopy (FURS) without the use of a ureteral access sheath. A percutaneous nephrostomy (PCN) tract is created using an 18G needle, and a 6F renal dilator is placed and fixed to the skin, allowing for direct suctioning from the collecting system. Following this, retrograde flexible ureteroscopy (FURS) is performed using the PUSEN® 9.2 Fr ureteroscope and Holmium Laser (JenaSurgical® MultiPulse HoPLUS™ 150W) for stone fragmentation. This technique aims to improve stone clearance while minimizing ureteral trauma associated with access sheaths.', 'armGroupLabels': ['Antegrade Suction with Flexible Ureteroscopy (FURS) Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tamer Diab, MD', 'role': 'CONTACT', 'email': 'tamer.diab@fmed.bu.edu.eg', 'phone': '01003583264', 'phoneExt': '+2'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '* Start Date: Upon publication of primary study results\n* End Date: Available for 5 years after study completion', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) will be shared, including baseline characteristics, intraoperative details, postoperative outcomes, and complication data for research purposes. No personally identifiable information will be disclosed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Urology, Faculty of Medicine.', 'investigatorFullName': 'Tamer Abd El-Wahab Diab', 'investigatorAffiliation': 'Benha University'}}}}