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

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ClinicalTrials.gov Identifier: NCT03870269
Recruitment Status : Enrolling by invitation
First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
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 : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Using Virtual Reality (VR) Models for Robotic Prostatectomy - UNC
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


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.



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 disccharge ]
  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

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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

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 ClinicalTrials.gov identifier (NCT number): NCT03870269


Locations
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United States, North Carolina
UNC Hospital
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
Ceevra, Inc.
Investigators
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Principal Investigator: Eric Wallen, MD University of North Carolina, Chapel Hill

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Responsible Party: Ceevra, Inc.
ClinicalTrials.gov Identifier: NCT03870269     History of Changes
Other Study ID Numbers: 17-0904RP
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No