NephrolithiasisNCT07668817
Tract Closure in PCNL
A study testing Floseal, Surgicel and Surgiflo in people with Nephrolithiasis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- Floseal, Surgicel and Surgiflo
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one stone ≥ 1.2cm
- Scheduled to undergo planned PCNL
- Age ≥ 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai West
New York, New York, 10019
Mantu Gupta, MD, 212-241-1272, mantu.gupta@mountsinai.org
Blair Gallante, MPH, 212-241-1272, blair.gallante@mountsinai.org
About this study
Official title: Defining the Role of Hemostatic Agents in Percutaneous Nephrolithotomy: A Randomized Controlled Trial of Tract Closure Techniques
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
- Being tested
- Floseal, Surgicel, Surgiflo, Balloon Tamponade
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlosealDevice
Floseal is an active, flowable hemostatic matrix designed to stop surgical bleeding fast, usually within 2 minutes, by combining gelatin granules with human thrombin.
SurgicelDevice
SURGICEL® (oxidized regenerated cellulose) is a plant-based, absorbable hemostatic fabric used to control capillary, venous, and small arterial bleeding.
SurgifloDevice
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 TamponadeProcedure or surgery
Balloon tamponade is utilized to manage tract related bleeding.
| Study group | Role | What they receive |
|---|---|---|
| Balloon Tamponade with no hemostatic agent | Active comparator | Balloon tamponade alone with no hemostatic agent acts as a control. Receives: Procedure: Balloon Tamponade |
| Balloon Tamponade with Floseal | Experimental | Balloon tamponade with Floseal as hemostatic agent. Receives: Device: Floseal; Procedure: Balloon Tamponade |
| Balloon Tamponade with Surgicel | Experimental | Balloon Tamponade with Surgicel as hemostatic agent. Receives: Device: Surgicel; Procedure: Balloon Tamponade |
| Balloon Tamponade with Surgiflo | Experimental | Balloon tamponade with Surgilfo as hemostatic agent. Receives: Device: Surgiflo; Procedure: Balloon Tamponade |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Post-operative Day 0
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: Post-operative Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start26 Oct 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mantu Gupta, Icahn School of Medicine at Mount Sinai
- Investigators
- Mantu Gupta, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668817
- Sponsor's protocol ID
- STUDY-26-00022
- Status last verified
- Sep 2026
- First submitted
- 28 May 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: To protect participant privacy
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Role of Hemostatic Agents in Percutaneous Nephrolithotomy: A Randomized Controlled Trial of Tract Closure Techniques
- ClinicalTrials.gov ID
- NCT07668817
- Acronym / sponsor ID
- STUDY-26-00022
- Conditions
- Nephrolithiasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Balloon Tamponade with no hemostatic agent | Active comparator | Procedure: Balloon TamponadeBalloon tamponade alone with no hemostatic agent acts as a control. |
| Balloon Tamponade with Floseal | Experimental | Device: Floseal, Procedure: Balloon TamponadeBalloon tamponade with Floseal as hemostatic agent. |
| Balloon Tamponade with Surgicel | Experimental | Device: Surgicel, Procedure: Balloon TamponadeBalloon Tamponade with Surgicel as hemostatic agent. |
| Balloon Tamponade with Surgiflo | Experimental | Device: Surgiflo, Procedure: Balloon TamponadeBalloon tamponade with Surgilfo as hemostatic agent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least one stone ≥ 1.2cm
- Scheduled to undergo planned PCNL
- Age ≥ 18 years
Key exclusion criteria (8 listed)
- Unable to provide informed consent
- Pre-existing nephrostomy tube
- Multi access cases
- Stone in calyceal diverticulum/hydrocalyx
- Preoperatively planned overnight admission for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlosealFloseal is an active, flowable hemostatic matrix designed to stop surgical bleeding fast, usually within 2 minutes, by combining gelatin granules with human thrombin. | Device | Balloon Tamponade with Floseal |
| SurgicelSURGICEL® (oxidized regenerated cellulose) is a plant-based, absorbable hemostatic fabric used to control capillary, venous, and small arterial bleeding. | Device | Balloon Tamponade with Surgicel |
| SurgifloSURGIFLO® Hemostatic Matrix is an Ethicon porcine gelatin-based, flowable hemostatic agent used to stop bleeding during surgery, typically reaching hemostasis within seconds to minutes. | Device | Balloon Tamponade with Surgiflo |
| Balloon TamponadeBalloon tamponade is utilized to manage tract related bleeding. | Procedure or surgery | Balloon Tamponade with Floseal, Balloon Tamponade with Surgicel, Balloon Tamponade with Surgiflo, Balloon Tamponade with no hemostatic agent |
Primary outcome
Change in hemoglobin from baseline to PACU
Time frame: Baseline and Post-operative Day 0
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No. To protect participant privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mantu Gupta, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Floseal, Surgicel and Surgiflo in people with Nephrolithiasis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mantu Gupta, MD (212-241-1272, mantu.gupta@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin from baseline to PACU (time frame: Baseline and Post-operative Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.