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Recruiting NCT07668817

Tract Closure in PCNL

No phase Interventional Nephrolithiasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Floseal, Surgicel, Surgiflo, Balloon Tamponade.
Who it may be relevant to
Registry conditions: Nephrolithiasis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Defining the Role of Hemostatic Agents in Percutaneous Nephrolithotomy: A Randomized Controlled Trial of Tract Closure Techniques

Overview

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.

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.

Primary outcome measures

  • Change in hemoglobin from baseline to PACU [Time frame: Baseline and Post-operative Day 0]
Secondary outcome measures (4)
  • Change in Hemoglobin from baseline to Post-operative Day 10 [Time frame: Baseline and Post-operative Day 10]
  • Ureteroscopic tract bleeding score [Time frame: Post-operative Day 0]
  • Proportion of participants undergoing stent placement [Time frame: Post-operative Day 0]
  • Number of bleeding related events [Time frame: Post-operative Day 30]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mount Sinai West — New York

Identifiers

NCT: NCT07668817 · STUDY-26-00022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗