Recruiting

Hemostatic Agent

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07668817

Conditions

Nephrolithiasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Floseal

Surgicel

Surgiflo

Balloon Tamponade

Study Details

Brief 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.

Conditions

Nephrolithiasis

Study ID

NCT07668817

Start date

Aug, 2026

Status verified date

Jul, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

92 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Floseal

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

SURGICEL® (oxidized regenerated cellulose) is a plant-based, absorbable hemostatic fabric used to control capillary, venous, and small arterial bleeding.

Surgiflo

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

Balloon tamponade is utilized to manage tract related bleeding.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Mantu Gupta, MD

212-241-1272mantu.gupta@mountsinai.org

Blair Gallante, MPH

212-241-1272blair.gallante@mountsinai.org

Locations

Mount Sinai West

Recruiting

New York, New York, United States, 10019

Contacts

Mantu Gupta, MD

212-241-1272mantu.gupta@mountsinai.org

Blair Gallante, MPH

212-241-1272blair.gallante@mountsinai.org

Principal Investigator:

Mantu Gupta, MD

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Aug 14, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-08-14.