Occlusion Balloon vs. 5FR Ureteral Catheter

Not Applicable

Recruiting

• Conditions: Kidney Stones

• Registration Number: NCT06798753
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-23
• Study First Submitted: 2025-01-23
• Study First Submitted QC: 2025-01-23
• Last Update Submitted: 2025-01-23
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of ureteral stone fragments identified endoscopically	During procedure	Endoscopic identification of ureteral stone fragments will be used to compare rate of ureteral stone fragments upon completion of PCNL while using OBC versus 5FR-UC.

Secondary Outcome Measures

Name	Time	Method
Length of procedure	During procedure	Length of procedure is a common procedural outcome of endourologic procedures.

Trial Locations

Locations (1)

Mount Sinai West; 🇺🇸 New York, New York, United States