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

NCT04329767 | Completed FDA Device

• 1 other identifier: ISI-IRIS-002
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 2

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.

Conditions

Kidney Cancer

Outcome Measures

Primary Outcomes (1)

• Clinical utility of IRIS 3D model with CT scans during Intra-Operative navigation

  1. Interpretation of the anatomy 2. Procedure efficiency, 3. Sufficient information to use intraoperatively, and 4. Impact on the clinical practice

  Intra-operative

Secondary Outcomes (1)

• Clinical utility of IRIS 3D model with CT scans during preoperative surgical planning

  Preoperative

Study Arms (2)

IRIS Arm

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

Device: IRIS 1.0

CT Arm

Utilize only the standard 2D CT scan preoperatively and intraoperatively

Interventions

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.

IRIS Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with kidney cancer who will undergo robotic-assisted partial or robotic-assisted radical nephrectomy.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (2)

Hackensack University Medical Center

Edison, New Jersey, 08837, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: September 18, 2020
• Primary Completion: February 3, 2023
• Study Completion: August 31, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

US (2)