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Using Virtual Reality (VR) Models for Robotic Prostatectomy

Sponsor
Ceevra, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03943368
Collaborator
(none)
20
Enrollment
6
Locations
2
Arms
41.2
Anticipated Duration (Months)
3.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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

Study Design

Study Type:
Interventional
Anticipated 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 :
Apr 25, 2019
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 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.
No Intervention: Control Arm

Subjects whose surgeon will only be viewing CT/MR images in connection with the case.

Outcome Measures

Primary Outcome Measures

  1. Total operative time [During procedure, not to exceed 12 hours]

Secondary Outcome Measures

  1. Blood loss (measured in cubic centimeters) [Measured at end of procedure, not to exceed 12 hours]

  2. Intraoperative conversion from robotic assisted laparoscopic procedure to open procedure [During procedure, not to exceed 12 hours]

  3. Intraoperative complication [During procedure, not to exceed 12 hours]

  4. Patient hospital stay [Measured at time of patient discharge, up to 10 days]

  5. Positive tumor margin (assessed via standard post-operative biopsy) [Measured 1-2 weeks after discharge]

  6. Postoperative Gleason Score [Measured up to 3 months after discharge]

  7. Postoperative oncologic stage (T stage) [Measured up to 3 months after discharge]

  8. Readmission [Measured up to 6 months after discharge]

  9. Postoperative prostate-specific antigen (PSA) [Measured up to 12 months after discharge]

  10. Postoperative erectile function [Measured via survey up to 18 months after discharge]

  11. Postoperative continence [Measured via survey up to 18 months after discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UCLA Urology Los Angeles California United States 90094
2 UC Irvine Orange California United States 92868
3 Mayo Clinic Florida Jacksonville Florida United States 32224
4 Mount Sinai Health System New York New York United States 10029
5 Swedish Urology Group Seattle Washington United States 98104
6 Swedish Medical Center Seattle Washington United States 98122

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ceevra, Inc.
ClinicalTrials.gov Identifier:
NCT03943368
Other Study ID Numbers:
  • 20171006RP
First Posted:
May 9, 2019
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
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

Study Results

No Results Posted as of Jul 21, 2022