Occlusion Balloon vs. 5FR Ureteral Catheter

NCT06798753 | Completed Results FDA Device

• 1 other identifier: STUDY-24-01650
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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).

Conditions

Kidney Stones

Keywords

percutaneous nephrolithotomy; PCNL; Occlusion Balloon Catheter; kidney stone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Length of Procedure

  During procedure, up to 5 hours

• Number of Participants With Intraoperative Complications

  During procedure, up to 5 hours

• Number of Participants With Stent Placement

  during procedure, up to 5 hours

Study Arms (2)

Occlusion Balloon Catheter

ACTIVE COMPARATOR

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

5FR Ureteral Catheter

ACTIVE COMPARATOR

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

Interventions

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.

Occlusion Balloon Catheter

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.

5FR Ureteral Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai West

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Mantu Gupta
• Organization: Icahn School of Medicine at Mount Sinai

mantu.gupta@mountsinai.org

212-241-1272

Study Officials

• Mantu Gupta, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: January 23, 2025
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: April 20, 2026
• Results First Posted: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)