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

CompletedOBSERVATIONAL
Enrollment

122

Participants

Timeline

Start Date

September 18, 2020

Primary Completion Date

February 3, 2023

Study Completion Date

August 31, 2023

Conditions
Kidney Cancer
Interventions
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.

Trial Locations (2)

14642

University of Rochester Medical Center, Rochester

08837

Hackensack University Medical Center, Edison

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Intuitive Surgical

INDUSTRY

NCT04329767 - 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 | Biotech Hunter | Biotech Hunter