Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Subjects whose surgeon will be viewing VR models in addition to the source CT/MR image in connection with the case. |
|
| Control Arm | No Intervention | Subjects whose surgeon will only be viewing CT/MR images in connection with the case. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceevra Reveal | Device | VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total operative time | During procedure, not to exceed 12 hours |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric Wallen, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Hospital | Chapel Hill | North Carolina | 27514 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 disccharge |
| Postoperative erectile function | Measured via survey up to 18 months after discharge |
| Postoperative continence | Measured via survey up to 18 months after discharge |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |