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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Using Virtual Reality (VR) Models for Robotic Prostatectomy

  • Clinicaltrials.gov identifier

    NCT03943368

  • Recruitment Status

    Enrolling by invitation

  • First Posted

    May 9, 2019

  • Last update posted

    February 10, 2021

Study Description

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:Prostate Cancer
  • Intervention/Treatment: Device: Ceevra Reveal
  • Phase: N/A

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: June 2021
  • Estimated Study Completion Date: June 2022

Arms and interventions

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.

Outcome Measures

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Locations

United States, California
UCLA Urology
Los Angeles

United States, California
UC Irvine
Orange

United States, Florida
Mayo Clinic Florida
Jacksonville

United States, New York
Mount Sinai Health System
New York

United States, Washington
Swedish Urology Group
Seattle

United States, Washington
Swedish Medical Center
Seattle

Sponsors and Collaborators

Ceevra, Inc.

Investigators

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

More Information

  • Responsible Party: Ceevra, Inc.
  • ClinicalTrials.gov Identifier: NCT03943368 History of Changes
  • Other Study ID Numbers: 20171006RP
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: February 10, 2021
  • Last Verified: February 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Additional relevant MeSH terms: Prostatic Neoplasms