Prostate Cancer Clinical Trial
Official title:
Using Virtual Reality (VR) Models for Robotic Prostatectomy
Verified date | July 2022 |
Source | Ceevra, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | September 30, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Florida | Jacksonville | Florida |
United States | UCLA Urology | Los Angeles | California |
United States | Mount Sinai Health System | New York | New York |
United States | UC Irvine | Orange | California |
United States | Swedish Medical Center | Seattle | Washington |
United States | Swedish Urology Group | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Ceevra, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total operative time | During procedure, not to exceed 12 hours | ||
Secondary | Blood loss (measured in cubic centimeters) | Measured at end of procedure, not to exceed 12 hours | ||
Secondary | Intraoperative conversion from robotic assisted laparoscopic procedure to open procedure | During procedure, not to exceed 12 hours | ||
Secondary | Intraoperative complication | During procedure, not to exceed 12 hours | ||
Secondary | Patient hospital stay | Measured at time of patient discharge, up to 10 days | ||
Secondary | Positive tumor margin (assessed via standard post-operative biopsy) | Measured 1-2 weeks after discharge | ||
Secondary | Postoperative Gleason Score | Measured up to 3 months after discharge | ||
Secondary | Postoperative oncologic stage (T stage) | Measured up to 3 months after discharge | ||
Secondary | Readmission | Measured up to 6 months after discharge | ||
Secondary | Postoperative prostate-specific antigen (PSA) | Measured up to 12 months after discharge | ||
Secondary | Postoperative erectile function | Measured via survey up to 18 months after discharge | ||
Secondary | Postoperative continence | Measured via survey up to 18 months after discharge |
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