Defining the Role of Hemostatic Agents in Percutaneous Nephrolithotomy: A Randomized Controlled Trial of Tract Closure Techniques
Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• At least one stone ≥ 1.2cm
• Scheduled to undergo planned PCNL
• Age ≥ 18 years
Locations
United States
New York
Mount Sinai West
RECRUITING
New York
Contact Information
Primary
Mantu Gupta, MD
mantu.gupta@mountsinai.org
212-241-1272
Backup
Blair Gallante, MPH
blair.gallante@mountsinai.org
212-241-1272
Time Frame
Start Date: 2026-08
Estimated Completion Date: 2028-06
Participants
Target number of participants: 92
Treatments
Active_comparator: Balloon Tamponade with no hemostatic agent
Balloon tamponade alone with no hemostatic agent acts as a control.
Experimental: Balloon Tamponade with Floseal
Balloon tamponade with Floseal as hemostatic agent.
Experimental: Balloon Tamponade with Surgicel
Balloon Tamponade with Surgicel as hemostatic agent.
Experimental: Balloon Tamponade with Surgiflo
Balloon tamponade with Surgilfo as hemostatic agent.
Related Therapeutic Areas
Sponsors
Leads: Icahn School of Medicine at Mount Sinai