Prostate Cancer
Conditions
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.
Interventions
DEVICECeevra Reveal
VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image.
Sponsors
Ceevra, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total operative time | During procedure, not to exceed 12 hours |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Blood loss (measured in cubic centimeters) | Measured at end of procedure, not to exceed 12 hours |
| Readmission | Measured up to 6 months after discharge |
| Postoperative prostate-specific antigen (PSA) | Measured up to 12 months after disccharge |
| Postoperative erectile function | Measured via survey up to 18 months after discharge |
| Postoperative continence | Measured via survey up to 18 months after discharge |
| Postoperative oncologic stage (T stage) | Measured up to 3 months after discharge |
Countries
United States
Outcome results
None listed