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COMPLETED
NCT06798753
NA

Occlusion Balloon vs. 5FR Ureteral Catheter

Sponsor: Icahn School of Medicine at Mount Sinai

View on ClinicalTrials.gov

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).

Official title: The Presence of Ureteral Calculi Upon Supine PCNL Completion: Occlusion Balloon Catheter Versus 5FR Ureteral Catheter

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2025-01-23

Completion Date

2025-08-29

Last Updated

2026-04-20

Healthy Volunteers

No

Conditions

Interventions

DEVICE

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.

DEVICE

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.

Locations (1)

Mount Sinai West

New York, New York, United States