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

Completed

• Conditions: Kidney Cancer
• Interventions: Device: IRIS 1.0

• Registration Number: NCT04329767
• Lead Sponsor: Intuitive Surgical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-03-30
• Study First Posted: 2020-04-01
• Study Start: 2020-09-18
• Primary Completion: 2023-02-03
• Study Completion: 2023-08-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IRIS Arm	IRIS 1.0	Utilize the CT scan along with the IRIS 3D model preoperatively and intraoperatively

Primary Outcome Measures

Name	Time	Method
Clinical utility of IRIS 3D model with CT scans during Intra-Operative navigation	Intra-operative	1. Interpretation of the anatomy; 2. Procedure efficiency,; 3. Sufficient information to use intraoperatively, and; 4. Impact on the clinical practice

Secondary Outcome Measures

Name	Time	Method
Clinical utility of IRIS 3D model with CT scans during preoperative surgical planning	Preoperative	1. Interpretation of the anatomy,; 2. Sufficient information to use preoperatively, and; 3. Confidence in completing the planned procedure.

Trial Locations

Locations (2)

Hackensack University Medical Center; 🇺🇸 Edison, New Jersey, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States