Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2025-01-23
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Occlusion Balloon Catheter
The occlusion balloon catheter (OBC) is a type of ureteral catheter equipped with a small inflatable balloon at its tip. When inflated, the balloon can help prevent the migration of stone fragments.
Occlusion Balloon Catheter
The occlusion balloon catheter (OBC) is a type of ureteral catheter equipped with a small inflatable balloon at its tip. When inflated, the balloon can help prevent the migration of stone fragments.
5FR Ureteral Catheter
The 5FR ureteral catheter (5FR-UC) is an open-ended small-caliber tube inserted at the beginning of PCNL to facilitate visualization of the collecting system using fluoroscopy and assist with renal access.
5FR Ureteral Catheter
The 5FR ureteral catheter (5FR-UC) is an open-ended small-caliber tube inserted at the beginning of PCNL to facilitate visualization of the collecting system using fluoroscopy and assist with renal access.
Interventions
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Occlusion Balloon Catheter
The occlusion balloon catheter (OBC) is a type of ureteral catheter equipped with a small inflatable balloon at its tip. When inflated, the balloon can help prevent the migration of stone fragments.
5FR Ureteral Catheter
The 5FR ureteral catheter (5FR-UC) is an open-ended small-caliber tube inserted at the beginning of PCNL to facilitate visualization of the collecting system using fluoroscopy and assist with renal access.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with kidney stones and scheduled for PCNL.
* Able and willing to provide informed consent.
Exclusion Criteria
* Urinary tract anomalies such as urinary diversion, previous ureteral reconstruction surgeries, horseshoe kidney, solitary kidney, duplicated system, urinary stricture disease, ureteropelvic junction obstruction, pelvic kidney, stone in calyceal diverticulum.
* Prone procedure
18 Years
ALL
No
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Mantu Gupta
Chair of Urology, MSW and MSM Hospitals Professor, Icahn School of Medicine at Mount Sinai Director of Endourology, Mount Sinai Medical Center Editor-in-Chief, Videourology
Principal Investigators
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Mantu Gupta, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Mount Sinai West
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY-24-01650
Identifier Type: -
Identifier Source: org_study_id
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