Tract Closure with Hemostatic Agent in PCNL
Official title: Defining the Role of Hemostatic Agents in Percutaneous Nephrolithotomy: A Randomized Controlled Trial of Tract Closure Techniques
Run by Icahn School of Medicine at Mount Sinai · NCT07668817 · Data updated 2026-11-12
This trial tests whether applying a hemostatic agent during tract closure in PCNL helps reduce blood loss compared with balloon tamponade alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 92 (estimated) |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | October 26, 2026 |
| Main results expected | May 2028 |
| Study ends | June 2028 |
| Registry record updated | September 18, 2026 |
| Trial ID | NCT07668817 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with at least one kidney stone ≥ 1.2 cm who are scheduled for planned PCNL and can provide informed consent.
✕Probably not a fit
Patients with complex anatomy, coagulation disorders, or multi-access PCNL may not benefit from the tested approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, randomized trial compares the use of a hemostatic agent during tract closure in percutaneous nephrolithotomy (PCNL) to balloon tamponade alone. Participants undergo standardized PCNL and are randomized to receive a hemostatic agent or no agent after tract closure. Outcomes focus on perioperative hemoglobin decline and tract-related bleeding, assessed after uniform balloon tamponade and irrigation-free endoscopic evaluation. The study uses defined inclusion criteria centered on adults with nephrolithiasis undergoing PCNL, excluding cases with certain anatomical or coagulation concerns. Interventions include Floseal, Surgicel, Surgiflo, and balloon tamponade.
Why it matters
Potential benefit: If successful, the approach could reduce blood loss and improve tract-related hemostasis during PCNL.
How similar studies have gone: Previous studies in other surgical settings have explored local hemostatic agents with varying success in reducing bleeding, but this exact application in PCNL is being tested here.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Mount Sinai West
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Mantu Gupta, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Mantu Gupta, MD
- Email: mantu.gupta@mountsinai.org
- Phone: 212-241-1272
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.