NCT06722807 ClAmpless, Sutureless PartIAl Nephrectomy for Renal Masses
| NCT ID | NCT06722807 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Renal Cell Carcinoma (RCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 59 participants |
| Start Date | 2025-06-10 |
| Primary Completion | 2026-08 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
During partial nephrectomy surgery, efforts at minimizing ischemia while maximizing renal parenchymal volume are desirable to preserve renal function1,2. Not only clamping of the hilum but the renorrhaphy portion of the procedure also can have a significant negative impact on renal function3-5. It is possible to perform this procedure without clamping the hilum and also without formal renorrhaphy. However robust prospective formal evaluation of safety, risks, and potential benefits and whether or not the technique can be employed in a generalized fashion has not been studied. Demonstration of safety and generalizability may open a whole new avenue of approaching nephron sparing and renal function sparing kidney surgery and decrease potential risks for long term kidney disease in patients with renal masses. This study will investigate the safety, efficacy, and generalizability of the use of clampless, sutureless partial nephrectomy in the treatment of renal cell carcinoma.
Eligibility Criteria
Inclusion Criteria: * Adults ≥ 18 years of age. * Patients undergoing partial nephrectomy for renal masses ≤ 7 cm * Subjects must not have more than one active malignancy at the time of enrollment. (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \[as determined by the treating physician or approved by the Principal Investigator\] may be included). * A clinical diagnosis consistent with renal cell carcinoma, cT1-3 N0 M0 without renal vein thrombus. * Adequate laboratory test results, including: 1. Platelets \> 50,000/µL 2. Hemoglobin \> 9.0 g/dL * Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures. * Subjects of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 2 weeks after surgery to m