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OpenTrials
Completed

NCT Number: NCT06798753

Occlusion Balloon vs. 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).

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Key information

Conditions

Kidney Stones Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai West

New York, 10019, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Occlusion Balloon Catheter

Device

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.

5FR Ureteral Catheter

Device

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.

Primary outcomes

  1. Number of Participants With Ureteral Stone Fragments Identified Endoscopically

    Time frame: During procedure, up to 5 hours

    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 outcomes

  1. Length of Procedure

    Time frame: During procedure, up to 5 hours

    Length of procedure is a common procedural outcome of endourologic procedures.

  2. Number of Participants With Intraoperative Complications

    Time frame: During procedure, up to 5 hours

    Number of participants with intraoperative complications, a common procedural outcome of endourologic procedures

  3. Number of Participants With Stent Placement

    Time frame: during procedure, up to 5 hours

    Number of participants with stent placement during procedure

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2025
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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