Using Virtual Reality (VR) Models for Robotic Prostatectomy - UNC

August 27, 2024 updated by: Ceevra, Inc.
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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ceevra, Inc.

Investigators

  • Principal Investigator: Eric Wallen, MD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2019

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

March 8, 2019

First Submitted That Met QC Criteria

March 8, 2019

First Posted (Actual)

March 12, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-0904RP

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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