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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IRIS Arm | Utilize the CT scan along with the IRIS 3D model preoperatively and intraoperatively |
| |
| CT Arm | Utilize only the standard 2D CT scan preoperatively and intraoperatively |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRIS 1.0 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical utility of IRIS 3D model with CT scans during Intra-Operative navigation |
| Intra-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical utility of IRIS 3D model with CT scans during preoperative surgical planning |
| Preoperative |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with kidney cancer who will undergo robotic-assisted partial or robotic-assisted radical nephrectomy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack University Medical Center | Edison | New Jersey | 08837 | United States | ||
| University of Rochester Medical Center |
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|
| Rochester |
| New York |
| 14642 |
| United States |
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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