Occlusion Balloon vs. 5FR Ureteral Catheter

Mount Sinai Health System

Status: Enrolling

Conditions: Kidney Stones

Treatments: Device: Occlusion Balloon Catheter; Device: 5FR Ureteral Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT06798753

STUDY-24-01650

Details and patient eligibility

About

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).

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18 years and older.
• Diagnosed with kidney stones and scheduled for PCNL.
• Able and willing to provide informed consent.

Exclusion criteria

• Pregnant women
• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Occlusion Balloon Catheter

Active Comparator group

Description:

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.

Treatment:

Device: Occlusion Balloon Catheter

5FR Ureteral Catheter

Active Comparator group

Description:

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.

Treatment:

Device: 5FR Ureteral Catheter