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

September 28, 2023 updated by: Intuitive Surgical
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Edison, New Jersey, United States, 08837
        • Hackensack University Medical Center
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IRIS Arm
Utilize the CT scan along with the IRIS 3D model preoperatively and intraoperatively
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.
CT Arm
Utilize only the standard 2D CT scan preoperatively and intraoperatively

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intuitive Surgical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2020

Primary Completion (Actual)

February 3, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

March 30, 2020

First Posted (Actual)

April 1, 2020

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISI-IRIS-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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