Clampless and Sutureless Robotic Partial Nephrectomy for the Treatment of Renal Cell Cancer, CASPIAN Trial

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 (PI)] may be included)
• A clinical diagnosis consistent with renal cell carcinoma, cT1-3 N0 M0 without renal vein thrombus
• Platelets > 50,000/μL
• 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 minimize the risk of pregnancy. Prior to study enrollment, subjects of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. SOCBP includes any subject who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopause is defined as: * Amenorrhea that has lasted for ≥ 12 consecutive months without another cause, or * For subjects with irregular menstrual periods who are taking hormone replacement therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35 mIU/mL

Exclusion Criteria

• Bleeding disorder (any congenital bleeding diathesis)
• Liver dysfunction with end stage liver disease as determined by the treating investigator
• Presence of renal vein thrombus
• End stage renal disease (estimated glomerular filtration rate [eGFR] < 15 using Cockcroft-gault formula or receiving renal replacement therapy [i.e. dialysis])
• Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 2 weeks after surgery
• Subjects who are confirmed to be pregnant or breastfeeding
• History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician
• Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness