Using Virtual Reality (VR) Models for Robotic Prostatectomy

Study Overview
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Brief Summary
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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.

Official Title
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Using Virtual Reality (VR) Models for Robotic Prostatectomy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Ceevra Reveal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Intervention Arm<br>Subjects whose surgeon will be viewing VR models in addition to the source CT/MR image in connection with the case. | Device: Ceevra Reveal<br>* VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image.<br>|
| No Intervention: Control Arm<br>Subjects whose surgeon will only be viewing CT/MR images in connection with the case. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total operative time |  | During procedure, not to exceed 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Intraoperative complication |  | During procedure, not to exceed 12 hours | 
| Patient hospital stay |  | Measured at time of patient discharge, up to 10 days | 
| Positive tumor margin (assessed via standard post-operative biopsy) |  | Measured 1-2 weeks after discharge | 
| Postoperative Gleason Score |  | Measured up to 3 months after discharge | 
| Postoperative oncologic stage (T stage) |  | Measured up to 3 months after discharge | 
| Readmission |  | Measured up to 6 months after discharge | 
| Postoperative prostate-specific antigen (PSA) |  | Measured up to 12 months after discharge | 
| Postoperative erectile function |  | Measured via survey up to 18 months after discharge | 
| Postoperative continence |  | Measured via survey up to 18 months after discharge |