| NCT ID | NCT07668817 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Nephrolithiasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2026-07 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 92 participants in total. It began in 2026-07 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Mantu Gupta, MD
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT07668817 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nephrolithiasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07668817 currently recruiting?
Yes, NCT07668817 is actively recruiting participants. Contact the research team at mantu.gupta@mountsinai.org for enrollment information.
Where is the NCT07668817 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07668817 clinical trial?
NCT07668817 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Mantu Gupta, MD at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 92 participants.