Tract Closure in PCNL

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07668817
Status
Recruiting
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Conditions

  • Nephrolithiasis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
May 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in hemoglobin from baseline to PACU [ Time Frame: Baseline and Post-operative Day 0 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai WestNew YorkNew York10019
Mantu Gupta, MD
[email protected]
212-241-1272
Blair Gallante, MPH
[email protected]
212-241-1272
Mantu Gupta, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Mount Sinai West· New York, NY

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