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.
Study Type
OBSERVATIONAL
Enrollment
122
Intuitive's IRIS 1.0 system is a software only device and service intended to create and deliver segmented image studies (3D anatomical models) based on patients computed tomography (CT) scans. It is intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multidimensional digital images.
Hackensack University Medical Center
Edison, New Jersey, United States
University of Rochester Medical Center
Rochester, New York, United States
Clinical utility of IRIS 3D model with CT scans during Intra-Operative navigation
1. Interpretation of the anatomy 2. Procedure efficiency, 3. Sufficient information to use intraoperatively, and 4. Impact on the clinical practice
Time frame: Intra-operative
Clinical utility of IRIS 3D model with CT scans during preoperative surgical planning
1. Interpretation of the anatomy, 2. Sufficient information to use preoperatively, and 3. Confidence in completing the planned procedure.
Time frame: Preoperative
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