Using Virtual Reality (VR) Models for Robotic Prostatectomy - UNC
Not Applicable
Completed
- Conditions
- Prostate Cancer
- Interventions
- Device: Ceevra Reveal
- Registration Number
- NCT03870269
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 28
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Arm Ceevra Reveal Subjects whose surgeon will be viewing VR models in addition to the source CT/MR image in connection with the case.
- Primary Outcome Measures
Name Time Method Total operative time During procedure, not to exceed 12 hours
- Secondary Outcome Measures
Name Time Method Postoperative oncologic stage (T stage) Measured up to 3 months after discharge Postoperative prostate-specific antigen (PSA) Measured up to 12 months after disccharge Intraoperative complication During procedure, not to exceed 12 hours Blood loss (measured in cubic centimeters) Measured at end of procedure, not to exceed 12 hours Intraoperative conversion from robotic assisted laparoscopic procedure to open procedure During procedure, not to exceed 12 hours Postoperative Gleason Score Measured up to 3 months after discharge Readmission Measured up to 6 months after discharge Patient hospital stay Measured at time of patient discharge, up to 10 days Postoperative erectile function Measured via survey up to 18 months after discharge Postoperative continence Measured via survey up to 18 months after discharge Positive tumor margin (assessed via standard post-operative biopsy) Measured 1-2 weeks after discharge
Trial Locations
- Locations (1)
UNC Hospital
🇺🇸Chapel Hill, North Carolina, United States