Kidney Cancer Clinical Trial
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)
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
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There are 2 Locations for this study
Edison New Jersey, 08837, United States
Rochester New York, 14642, United States
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