RecruitingNot ApplicableNCT07668817

Tract Closure in PCNL

Defining the Role of Hemostatic Agents in Percutaneous Nephrolithotomy: A Randomized Controlled Trial of Tract Closure Techniques


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

92 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, randomized controlled trial evaluating the effect of a hemostatic agent on tract-related bleeding during percutaneous nephrolithotomy (PCNL). Patients undergoing standardized PCNL will be randomized to receive either application of a hemostatic agent or no agent during tract closure, following uniform balloon occlusion, complete aspiration, and irrigation-free endoscopic assessment. The researchers hypothesize that adjunctive hemostatic agent use reduces perioperative hemoglobin decline compared with balloon tamponade alone and improves tract-related hemostasis outcomes.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Balloon Tamponade, a medical device called Floseal, and others for people with nephrolithiasis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFloseal

Floseal is an active, flowable hemostatic matrix designed to stop surgical bleeding fast, usually within 2 minutes, by combining gelatin granules with human thrombin.

DEVICESurgicel

SURGICEL® (oxidized regenerated cellulose) is a plant-based, absorbable hemostatic fabric used to control capillary, venous, and small arterial bleeding.

DEVICESurgiflo

SURGIFLO® Hemostatic Matrix is an Ethicon porcine gelatin-based, flowable hemostatic agent used to stop bleeding during surgery, typically reaching hemostasis within seconds to minutes.

PROCEDUREBalloon Tamponade

Balloon tamponade is utilized to manage tract related bleeding.


Locations(1)

Mount Sinai West

New York, New York, United States

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NCT07668817


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