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Tract Closure in PCNL
Defining the Role of Hemostatic Agents in Percutaneous Nephrolithotomy: A Randomized Controlled Trial of Tract Closure Techniques
Who can join
Ages 18 and older · All sexes
Full 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
About the study
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.
What is being tested
- Floseal (device)
- Surgicel (device)
- Surgiflo (device)
- Balloon Tamponade (procedure)
Sponsor: Icahn School of Medicine at Mount Sinai · Participants: 92 · Started: Oct 26, 2026
Contact the study team
- Mantu Gupta, MD · Phone: 212-241-1272
- Blair Gallante, MPH · Phone: 212-241-1272
Official record on ClinicalTrials.gov — NCT07668817
Locations in the U.S.
| New York | Mount Sinai West, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.