A Prospective Post-Market Study to Evaluate the Clinical Utility of IRIS, a Three-dimensional (3-D) Anatomical Modeling Software for Pre-operative Surgical Planning and Intra-operative Navigation for Nephrectomy
This is a prospective, multi-center, post-market study to evaluate the clinical utility of IRIS, a 3D anatomical modeling software, with standard CT scans during pre-operative planning and intra-operative navigation for nephrectomy. The study will be conducted over the course of 21-24 months and enroll approximately 60-120 subjects.
Subject is 18 years or older Subject is undergoing robotic-assisted partial or robotic-assisted radical nephrectomy being performed by participating surgeon Subjects who has had or plan to have a CT scan (with IV contrast medium)
Exclusion Criteria:
Subject has a solitary or horseshoe kidney Subject has more than two masses in the applicable kidney requiring multiple partial nephrectomies on the same kidney Subject with prior surgery (ex: partial nephrectomy etc.) on the affected kidney excluding endoscopic kidney stone surgery Subject with renal vein tumor thrombus Subjects planned to have a bilateral operation (ex: bilateral partial nephrectomies planned at the same time) Metastatic disease with life expectancy of less than 1 year Pregnant or suspect pregnancy Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent Subject belonging to other vulnerable population, e.g, prisoner or ward of the state
