Clinical trial · Interventional
Using Virtual Reality (VR) Models for Robotic Prostatectomy
NCT03943368CI-TRIAL-00077685completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ceevra Reveal | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: Intervention Arm
- description
- Subjects whose surgeon will be viewing Digital 3D models in addition to the source MR image and biopsy results in connection with the case.
- interventionNames
- Device: Ceevra Reveal
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- Subjects whose surgeon will only be viewing MR images in connection with the case.
Primary outcomes (1)
- measure
- Postoperative PSA
- timeFrame
- Up to 24 months
- description
- PSA blood test measured at threshold of 0.1 at 3-6 and 18-24 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDShirk 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. PMID 39283633
- DERIVEDShirk 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. PMID 35848770