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

Kidney Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04329767
• Other study ID #: ISI-IRIS-002
• Status: Completed
• Start date: September 18, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: September 2023
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 31, 2023
• Est. primary completion date: February 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Cancer
• Kidney Neoplasms

Intervention

Device:
• IRIS 1.0
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.

Locations

Country	Name	City	State
United States	Hackensack University Medical Center	Edison	New Jersey
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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