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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hackensack University Medical Center, Edison, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

Time frame: Intra-operative
- Interpretation of the anatomy
- Procedure efficiency,
- Sufficient information to use intraoperatively, and
- Impact on the clinical practice

Secondary outcomes

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

Time frame: Preoperative
- Interpretation of the anatomy,
- Sufficient information to use preoperatively, and
- Confidence in completing the planned procedure.

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Apr 1, 2020
Registry last updated: Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed