Using Virtual Reality (VR) Models for Robotic Prostatectomy - UNC
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable prostate-cancer
Started Feb 2019
Typical duration for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2019
CompletedFirst Submitted
Initial submission to the registry
March 8, 2019
CompletedFirst Posted
Study publicly available on registry
March 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedAugust 28, 2024
August 1, 2024
4.6 years
March 8, 2019
August 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Total operative time
During procedure, not to exceed 12 hours
Secondary Outcomes (11)
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
- +6 more secondary outcomes
Study Arms (2)
Intervention Arm
EXPERIMENTALSubjects whose surgeon will be viewing VR models in addition to the source CT/MR image in connection with the case.
Control Arm
NO INTERVENTIONSubjects whose surgeon will only be viewing CT/MR images in connection with the case.
Interventions
VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image.
Eligibility Criteria
You may qualify if:
- Patient is undergoing robotic prostatectomy being performed by participating surgeon
- Patient is willing to be randomized between intervention and control arms
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ceevra, Inc.lead
Study Sites (1)
UNC Hospital
Chapel Hill, North Carolina, 27514, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Wallen, MD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2019
First Posted
March 12, 2019
Study Start
February 25, 2019
Primary Completion
September 30, 2023
Study Completion
September 30, 2023
Last Updated
August 28, 2024
Record last verified: 2024-08