An Evaluation of a Powered Vascular Stapler in Laparoscopic Nephrectomies and Nephroureterectomies

A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in Laparoscopic Nephrectomies and Nephroureterectomies

This prospective, randomized, controlled, multi-center study will collect and compare data from the surgeon's current standard of care stapler (for renal artery and renal vein transection) and powered vascular stapler

Inclusion Criteria:

• Scheduled for a simple or radical laparoscopic nephrectomy or a laparoscopic nephroureterectomy in accordance with the institution's standard of care (SOC);
• Performance status 0-1 (Eastern Cooperative Oncology Group classification), if applicable;
• American Society of Anesthesiologists (ASA) score < 3;
• No prior history of partial or wedge nephrectomy (on the kidney in which the procedure will be performed);
• Willing to give consent and comply with study-related evaluation and treatment schedule; and
• At least 18 years of age

Exclusion Criteria:

• Prior chemotherapy or radiation (within 30 days prior to the procedure or the duration of the subject's enrollment);
• Pregnancy;
• Physical or psychological condition which would impair study participation; or
• The subject is judged unsuitable for study participation by the Investigator for any other reason.