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 |
|---|---|---|---|
| Experimental: Intervention Arm | Experimental | Subjects whose surgeon will be viewing Digital 3D models in addition to the source MR image and biopsy results in connection with the case. |
|
| Control Arm | No Intervention | Subjects whose surgeon will only be viewing MR images in connection with the case. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceevra Reveal | Device | 3D Digital models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source MR image. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative PSA | PSA blood test measured at threshold of 0.1 at 3-6 and 18-24 months | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Margin Status | Defined as positive or negative surgical margin | Immediately postoperatively |
| Androgen Deprivation or Radiation Therapy | Any occurrence of salvage or adjuvant therapy post surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James Porter, MD | Swedish Medical Center | Principal Investigator |
| Raymond Pak, MD | Mayo Clinic | Principal Investigator |
| Thomas Ahlering, MD | UC Irvine | Principal Investigator |
| Robert Reiter, MD | UCLA Urology | Principal Investigator |
| Ketan Badani, MD | Mount Sinai Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Urology | Los Angeles | California | 90094 | United States | ||
| UC Irvine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39283633 | Derived | Shirk JD, Reiter RE, Wallen EM, Pak RW, Ahlering T, Badani KK, Porter JR. Trifecta Outcomes After Use of 3-Dimensional Digital Models for Planning of Robotic Prostatectomy: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2434143. doi: 10.1001/jamanetworkopen.2024.34143. | |
| 35848770 | Derived |
Not provided
Not provided
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
| Up to 24 months postoperatively |
| Postoperative Erectile Function | Nerve sparing immediately postoperatively, SHIM score at 3-6 and 18-24 months | Up to 24 months postoperatively |
| Postoperative Urinary Function | Bladder neck sparing immediately postoperatively, pads per day at 3-6 and 18-24 months | Up to 24 months postoperatively |
| Orange |
| California |
| 92868 |
| United States |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
| Mount Sinai Health System | New York | New York | 10029 | United States |
| Swedish Urology Group | Seattle | Washington | 98104 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Shirk JD, Reiter R, Wallen EM, Pak R, Ahlering T, Badani KK, Porter JR. Effect of 3-Dimensional, Virtual Reality Models for Surgical Planning of Robotic Prostatectomy on Trifecta Outcomes: A Randomized Clinical Trial. J Urol. 2022 Sep;208(3):618-625. doi: 10.1097/JU.0000000000002719. Epub 2022 Jul 18. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |