Status:
COMPLETED
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
Lead Sponsor:
Intuitive Surgical
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Brief Summary
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-opera...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT04329767
Start Date
September 18 2020
End Date
August 31 2023
Last Update
September 29 2023
Active Locations (2)
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1
Hackensack University Medical Center
Edison, New Jersey, United States, 08837
2
University of Rochester Medical Center
Rochester, New York, United States, 14642