Occlusion Balloon vs. 5FR Ureteral Catheter

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

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).

Study Overview

• Status: Completed
• Conditions: Kidney Stones
• Intervention / Treatment: Device: Occlusion Balloon Catheter; Device: 5FR Ureteral Catheter

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Mount Sinai West

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Ureteral Stone Fragments Identified Endoscopically	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.	During procedure, up to 5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Procedure	Length of procedure is a common procedural outcome of endourologic procedures.	During procedure, up to 5 hours
Number of Participants With Intraoperative Complications	Number of participants with intraoperative complications, a common procedural outcome of endourologic procedures	During procedure, up to 5 hours
Number of Participants With Stent Placement	Number of participants with stent placement during procedure	during procedure, up to 5 hours

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Mantu Gupta, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2025
• Primary Completion (Actual): August 29, 2025
• Study Completion (Actual): August 29, 2025

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): January 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: percutaneous nephrolithotomy; kidney stone; PCNL; Occlusion Balloon Catheter
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Nephrolithiasis; Pathological Conditions, Signs and Symptoms; Kidney Calculi
• Other Study ID Numbers: STUDY-24-01650

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results will be shared in aggregate to protect subject privacy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes