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Tract Closure in PCNL

NCT07668817 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-08-14

No results posted yet for this study

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

Interventions

DEVICE

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.

DEVICE

Surgicel

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

DEVICE

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.

PROCEDURE

Balloon Tamponade

Balloon tamponade is utilized to manage tract related bleeding.

Sponsors & Collaborators

Principal Investigators

  • Mantu Gupta, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-05-31
Completion
2028-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07668817 on ClinicalTrials.gov