Using Virtual Reality (VR) Models for Preoperative Planning

A prospective, randomized, controlled study designed to assess whether digital virtual reality (VR) models, created from existing CT scans and MRIs, provide surgeons with an improved understanding of their patients' anatomy, resulting in more efficient operations (robotic partial nephrectomy) and improved patient care.

Study Overview

• Status: Completed
• Conditions: Kidney Cancer; Renal Cell Carcinoma
• Intervention / Treatment: Device: Ceevra Reveal

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • John Wayne Cancer Institute at Providence St. John's Heath Center
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina, Chapel Hill
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Urology Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is undergoing robotic partial nephrectomy being performed by participating surgeon
• Subject is willing to be randomized between intervention and control arms

Exclusion Criteria:

• Cases involving subjects who are minors, pregnant or require an authorized representative for informed consent
• Cases in which the subject has a solitary or horseshoe kidney
• Cases in which the subject has more than two masses in the applicable kidney
• Cases involving a bilateral operation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Subjects whose surgeon will be viewing VR models in connection with the in addition to the source CT/MR image	Device: Ceevra Reveal; VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image.
No Intervention: Control Arm; Subjects whose surgeon will only be viewing CT/MR images in connection with the case

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Operative Time	During procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Loss		Measured at end of procedure
Clamp Time		Measured at end of procedure
Number of Patients With Conversion to Open Surgery		During procedure
Number of Patients With Conversion to Radical Nephrectomy		During procedure
Number of Patients With an Intraoperative Complication		During procedure
Patient Hospital Stay		Measured at time of patient discharge, up to 10 days
Number of Patients With a Positive Surgical Margin	Incomplete removal of tumor as defined by the surgical pathology	Measured 1-2 weeks after discharge
Post-Op Complication		Measured up to 6 months after discharge
Readmission		Measured up to 6 months after discharge

Collaborators and Investigators

• Sponsor: Ceevra, Inc.

Publications and helpful links

General Publications

• Shirk JD, Thiel DD, Wallen EM, Linehan JM, White WM, Badani KK, Porter JR. Effect of 3-Dimensional Virtual Reality Models for Surgical Planning of Robotic-Assisted Partial Nephrectomy on Surgical Outcomes: A Randomized Clinical Trial. JAMA Netw Open. 2019 Sep 4;2(9):e1911598. doi: 10.1001/jamanetworkopen.2019.11598.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2017
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): March 18, 2019

Study Registration Dates

• First Submitted: November 1, 2017
• First Submitted That Met QC Criteria: November 2, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: 20171006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No