The Presence of Ureteral Calculi Upon Supine PCNL Completion: Occlusion Balloon Catheter Versus 5FR Ureteral Catheter
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Occlusion Balloon catheter provides the ability to occlude the exit of the kidney pelvis during percutaneous nephrolithotomy (PCNL) and potentially prevents the migration of stone fragments into the ureter. The necessity for it might be questioned during supine PCNL due to the upward oblique position of the kidney. The objective of the study is to compare the presence of ureteral stone fragments upon completion of supine PCNL with and without using an occlusion balloon catheter (OBC).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adults aged 18 years and older.
• Diagnosed with kidney stones and scheduled for PCNL.
• Able and willing to provide informed consent.
Locations
United States
New York
Mount Sinai West
RECRUITING
New York
Contact Information
Primary
Blair Gallante, MPH
blair.gallante@mountsinai.org
631-991-1159
Backup
Mantu Gupta, MD
mantu.gupta@mountsinai.org
212-241-1272
Time Frame
Start Date: 2025-01-23
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 110
Treatments
Active_comparator: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Icahn School of Medicine at Mount Sinai