An interventional study of Floseal and Surgicel in Nephrolithiasis, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
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.
324 studies on the registry are indexed under Nephrolithiasis; 90 are open to participants now.
This study's planned enrollment of 92 is close to the median of 92 across 257 interventional studies indexed under Nephrolithiasis.
Browse Nephrolithiasis studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Balloon tamponade alone with no hemostatic agent acts as a control.
Procedure: Balloon Tamponade
Balloon tamponade with Floseal as hemostatic agent.
Device: Floseal · Procedure: Balloon Tamponade
Balloon Tamponade with Surgicel as hemostatic agent.
Device: Surgicel · Procedure: Balloon Tamponade
Balloon tamponade with Surgilfo as hemostatic agent.
Device: Surgiflo · Procedure: Balloon Tamponade
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® (oxidized regenerated cellulose) is a plant-based, absorbable hemostatic fabric used to control capillary, venous, and small arterial bleeding.
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 is utilized to manage tract related bleeding.
Change in hemoglobin from baseline to PACU
Change in Hemoglobin from preoperative baseline CBC to PACU CBC. A hemoglobin test measures the levels of hemoglobin in the blood. Hemoglobin is an iron-rich protein in the red blood cells. It carries oxygen from the lungs to the rest of the body. Cells need oxygen to grow, reproduce, and make energy to function. Hemoglobin levels provide information about the health of red blood cells.
Time frame: Baseline and Post-operative Day 0
Change in Hemoglobin from baseline to Post-operative Day 10
Change in Hemoglobin from preoperative baseline CBC to postoperative day 10 CBC. A hemoglobin test measures the levels of hemoglobin in the blood. Hemoglobin is an iron-rich protein in the red blood cells. It carries oxygen from the lungs to the rest of the body. Cells need oxygen to grow, reproduce, and make energy to function. Hemoglobin levels provide information about the health of red blood cells.
Time frame: Baseline and Post-operative Day 10
Ureteroscopic tract bleeding score
Ureteroscopic tract bleeding score provides a direct, anatomically specific measure of tract hemostasis that complements laboratory-based bleeding outcomes. Bleeding score is based on a 0-3 ordinal scale. 0 equals no visible tract bleeding whereas 3 equals active tract bleeding that significantly impairs visualization. Higher score indicates more bleeding and poor health outcome.
Time frame: Post-operative Day 0
Proportion of participants undergoing stent placement
Proportion of participants undergoing stent placement at procedure completion. Drainage decisions reflect surgeon assessment of tract bleeding and represent a clinically meaningful downstream consequence of hemostasis. This is measured as a binary patient-level outcome (stent placed: yes/no)
Time frame: Post-operative Day 0
Number of bleeding related events
Number of bleeding related events within 30 days ensures adjunctive hemostatic agent use does not introduce excess bleeding-related morbidity.
Time frame: Post-operative Day 30
Plan to share: No — To protect participant privacy
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Icahn School of Medicine at Mount Sinai →