Using Virtual Reality (VR) Models for Robotic Prostatectomy - UNC

Ceevra, Inc.1 site in 1 country28 target enrollmentFebruary 25, 2019

ConditionsProstate Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Ceevra, Inc.
Enrollment: 28
Locations: 1
Primary Endpoint: Total operative time
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 25, 2019

End Date

September 30, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Ceevra, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Total operative time

Time Frame: During procedure, not to exceed 12 hours

Secondary Outcomes

Postoperative oncologic stage (T stage)(Measured up to 3 months after discharge)
Postoperative prostate-specific antigen (PSA)(Measured up to 12 months after disccharge)
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)
Postoperative Gleason Score(Measured up to 3 months after discharge)
Readmission(Measured up to 6 months after discharge)
Intraoperative complication(During procedure, not to exceed 12 hours)
Patient hospital stay(Measured at time of patient discharge, up to 10 days)
Postoperative erectile function(Measured via survey up to 18 months after discharge)
Postoperative continence(Measured via survey up to 18 months after discharge)
Positive tumor margin (assessed via standard post-operative biopsy)(Measured 1-2 weeks after discharge)