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

Study Overview
=================
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-operative navigation for nephrectomy. The study will be conducted over the course of 21-24 months and enroll approximately 60-120 subjects.

Official Title
-----------------
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

Conditions
-----------------
Kidney Cancer

Intervention / Treatment
-----------------
* Device: IRIS 1.0


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IRIS Arm<br>Utilize the CT scan along with the IRIS 3D model preoperatively and intraoperatively | Device: IRIS 1.0<br>* 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.<br>|
| CT Arm<br>Utilize only the standard 2D CT scan preoperatively and intraoperatively | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical utility of IRIS 3D model with CT scans during Intra-Operative navigation | Interpretation of the anatomy Procedure efficiency, Sufficient information to use intraoperatively, and Impact on the clinical practice | Intra-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical utility of IRIS 3D model with CT scans during preoperative surgical planning | Interpretation of the anatomy, Sufficient information to use preoperatively, and Confidence in completing the planned procedure. | Preoperative |