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RECRUITING Not applicable ClinicalTrials.gov

Tract Closure in PCNL

Sponsor: Icahn School of Medicine at Mount Sinai • ClinicalTrials.gov ID: NCT07668817

Registry updated: 2026-09-18
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Description

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.

Interventions

  • Floseal (Device)
    Floseal is an active, flowable hemostatic matrix designed to stop surgical bleeding fast, usually within 2 minutes, by combining gelatin granules with human thrombin.
  • Surgicel (Device)
    SURGICEL® (oxidized regenerated cellulose) is a plant-based, absorbable hemostatic fabric used to control capillary, venous, and small arterial bleeding.
  • Surgiflo (Device)
    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.
  • Balloon Tamponade (Procedure)
    Balloon tamponade is utilized to manage tract related bleeding.

Eligibility criteria

Inclusion criteria: * At least one stone ≥ 1.2cm * Scheduled to undergo planned PCNL * Age ≥ 18 years Exclusion criteria: * Unable to provide informed consent * Pre-existing nephrostomy tube * Multi access cases * Stone in calyceal diverticulum/hydrocalyx * Preoperatively planned overnight admission for any reason * Infundibular stenosis * Coagulation disorders * Other significant anatomic abnormalities

Conditions

Nephrolithiasis

Locations

  • Mount Sinai West — New York, New York, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record