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
Completed
Conditions studied: Kidney Cancer
In brief
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.
Key facts
- Study ID
- NCT04329767
- Run by
- Intuitive Surgical
- People needed
- 122
- Starts
- 2020-09-18
- Expected to finish
- 2023-08-31
- Last updated by the study team
- 2023-09-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Hackensack University Medical Center — Edison, New Jersey, United States
- University of Rochester Medical Center — Rochester, New York, United States
Full record on ClinicalTrials.gov
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