Occlusion Balloon vs. 5FR Ureteral Catheter

NCT ID: NCT06798753

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-23

Study Completion Date

2026-07-31

Brief Summary

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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

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Conditions

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Kidney Stones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Occlusion Balloon Catheter

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

5FR Ureteral Catheter

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Mantu Gupta

Chair of Urology, MSW and MSM Hospitals Professor, Icahn School of Medicine at Mount Sinai Director of Endourology, Mount Sinai Medical Center Editor-in-Chief, Videourology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mantu Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Mount Sinai West

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Blair Gallante, MPH

Role: CONTACT

631-991-1159

Mantu Gupta, MD

Role: CONTACT

212-241-1272

Facility Contacts

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Mantu Gupta, MD

Role: primary

212-241-1272

Blair Gallante, MPH

Role: backup

631-991-1159

Other Identifiers

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STUDY-24-01650

Identifier Type: -

Identifier Source: org_study_id

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