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Using Virtual Reality (VR) Models for Robotic Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03943368
Recruitment Status : Enrolling by invitation
First Posted : May 9, 2019
Last Update Posted : July 17, 2020
Information provided by (Responsible Party):
Ceevra, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Ceevra Reveal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Using Virtual Reality (VR) Models for Robotic Prostatectomy
Actual Study Start Date : April 25, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

No Intervention: Control Arm
Subjects whose surgeon will only be viewing CT/MR images in connection with the case.

Primary Outcome Measures :
  1. Total operative time [ Time Frame: During procedure, not to exceed 12 hours ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03943368

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United States, California
UCLA Urology
Los Angeles, California, United States, 90094
UC Irvine
Orange, California, United States, 92868
United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
United States, New York
Mount Sinai Health System
New York, New York, United States, 10029
United States, Washington
Swedish Urology Group
Seattle, Washington, United States, 98104
Swedish Medical Center
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Ceevra, Inc.
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Principal Investigator: James Porter, MD Swedish Medical Center
Principal Investigator: Raymond Pak, MD Mayo Clinic
Principal Investigator: Thomas Ahlering, MD UC Irvine
Principal Investigator: Robert Reiter, MD UCLA Urology
Principal Investigator: Ketan Badani, MD Mount Sinai Health System
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Responsible Party: Ceevra, Inc. Identifier: NCT03943368    
Other Study ID Numbers: 20171006RP
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases