Using Virtual Reality (VR) Models for Robotic Prostatectomy

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 prostatectomy) and improved patient care.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Ceevra Reveal

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90094
      • UCLA Urology
    • Orange, California, United States, 92868
      • UC Irvine
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Health System
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
    • 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: Male

Description

Inclusion Criteria:

• Patient is undergoing robotic prostatectomy being performed by participating surgeon
• Patient is willing to be randomized between intervention and control arms

Exclusion Criteria:

• Patients with prior pelvic radiation
• Patients with prior androgen deprivation therapy
• Patients with prior localized ablative therapy
• Patients with prior TURP or other surgical BPH treatment

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; Subjects whose surgeon will only be viewing CT/MR images in connection with the case.
Experimental: Experimental: Intervention Arm; Subjects whose surgeon will be viewing VR models in addition to the source CT/MR image in connection with the case.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total operative time	During procedure, not to exceed 12 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Readmission	Measured up to 6 months after discharge
Blood loss (measured in cubic centimeters)	Measured at end of procedure, not to exceed 12 hours
Intraoperative conversion from robotic assisted laparoscopic procedure to open procedure	During procedure, not to exceed 12 hours
Intraoperative complication	During procedure, not to exceed 12 hours
Patient hospital stay	Measured at time of patient discharge, up to 10 days
Positive tumor margin (assessed via standard post-operative biopsy)	Measured 1-2 weeks after discharge
Postoperative Gleason Score	Measured up to 3 months after discharge
Postoperative oncologic stage (T stage)	Measured up to 3 months after discharge
Postoperative erectile function	Measured via survey up to 18 months after discharge
Postoperative continence	Measured via survey up to 18 months after discharge
Postoperative prostate-specific antigen (PSA)	Measured up to 12 months after discharge

Collaborators and Investigators

• Sponsor: Ceevra, Inc.
• Investigators: Principal Investigator: Thomas Ahlering, MD, UC Irvine; Principal Investigator: Raymond Pak, MD, Mayo Clinic; Principal Investigator: Robert Reiter, MD, UCLA Urology; Principal Investigator: Ketan Badani, MD, Mount Sinai Health System

Publications and helpful links

General Publications

• Shirk JD, Reiter R, Wallen EM, Pak R, Ahlering T, Badani KK, Porter JR. Effect of 3-Dimensional, Virtual Reality Models for Surgical Planning of Robotic Prostatectomy on Trifecta Outcomes: A Randomized Clinical Trial. J Urol. 2022 Sep;208(3):618-625. doi: 10.1097/JU.0000000000002719. Epub 2022 Jul 18.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2019
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 21, 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; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 20171006RP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes