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NCT07668817NARecruiting

Tract Closure in PCNL

Icahn School of Medicine at Mount Sinai

Start Date

7/1/2026

Completion Date

6/1/2028

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Floseal

DEVICE

Surgicel

DEVICE

Surgiflo

PROCEDURE

Balloon Tamponade

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Conditions

Nephrolithiasis

Locations

Mount Sinai West

New York, New York 10019

United States