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

Intuitive Surgical

Status: Completed

Conditions: Kidney Cancer

Treatments: Device: IRIS 1.0

Study type: Observational

Funder types: Industry

Identifiers

NCT04329767

ISI-IRIS-002

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is 18 years or older
2. Subject is undergoing robotic-assisted partial or robotic-assisted radical nephrectomy being performed by participating surgeon
3. Subjects who has had or plan to have a CT scan (with IV contrast medium)

Exclusion criteria

1. Subject has a solitary or horseshoe kidney
2. Subject has more than two masses in the applicable kidney requiring multiple partial nephrectomies on the same kidney
3. Subject with prior surgery (ex: partial nephrectomy etc.) on the affected kidney excluding endoscopic kidney stone surgery
4. Subject with renal vein tumor thrombus
5. Subjects planned to have a bilateral operation (ex: bilateral partial nephrectomies planned at the same time)
6. Metastatic disease with life expectancy of less than 1 year
7. Pregnant or suspect pregnancy
8. 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
9. Subject belonging to other vulnerable population, e.g, prisoner or ward of the state

Trial design

122 participants in 2 patient groups

IRIS Arm

Description:

Utilize the CT scan along with the IRIS 3D model preoperatively and intraoperatively

Treatment:

Device: IRIS 1.0

CT Arm

Description:

Utilize only the standard 2D CT scan preoperatively and intraoperatively