Back to resultsUsing Virtual Reality (VR) Models for Robotic Prostatectomy - UNC
Primary Purpose
Prostate Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ceevra Reveal
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
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
Sites / Locations
- UNC Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Arm
Control Arm
Arm Description
Subjects whose surgeon will be viewing VR models in addition to the source CT/MR image in connection with the case.
Subjects whose surgeon will only be viewing CT/MR images in connection with the case.
Outcomes
Primary Outcome Measures
Total operative time
Secondary Outcome Measures
Blood loss (measured in cubic centimeters)
Intraoperative conversion from robotic assisted laparoscopic procedure to open procedure
Intraoperative complication
Patient hospital stay
Positive tumor margin (assessed via standard post-operative biopsy)
Postoperative Gleason Score
Postoperative oncologic stage (T stage)
Readmission
Postoperative prostate-specific antigen (PSA)
Postoperative erectile function
Postoperative continence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03870269
Brief Title
Using Virtual Reality (VR) Models for Robotic Prostatectomy - UNC
Official Title
Using Virtual Reality (VR) Models for Robotic Prostatectomy - UNC
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 25, 2019 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ceevra, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Subjects whose surgeon will be viewing VR models in addition to the source CT/MR image in connection with the case.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Subjects whose surgeon will only be viewing CT/MR images in connection with the case.
Intervention Type
Device
Intervention Name(s)
Ceevra Reveal
Intervention Description
VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image.
Primary Outcome Measure Information:
Title
Total operative time
Time Frame
During procedure, not to exceed 12 hours
Secondary Outcome Measure Information:
Title
Blood loss (measured in cubic centimeters)
Time Frame
Measured at end of procedure, not to exceed 12 hours
Title
Intraoperative conversion from robotic assisted laparoscopic procedure to open procedure
Time Frame
During procedure, not to exceed 12 hours
Title
Intraoperative complication
Time Frame
During procedure, not to exceed 12 hours
Title
Patient hospital stay
Time Frame
Measured at time of patient discharge, up to 10 days
Title
Positive tumor margin (assessed via standard post-operative biopsy)
Time Frame
Measured 1-2 weeks after discharge
Title
Postoperative Gleason Score
Time Frame
Measured up to 3 months after discharge
Title
Postoperative oncologic stage (T stage)
Time Frame
Measured up to 3 months after discharge
Title
Readmission
Time Frame
Measured up to 6 months after discharge
Title
Postoperative prostate-specific antigen (PSA)
Time Frame
Measured up to 12 months after disccharge
Title
Postoperative erectile function
Time Frame
Measured via survey up to 18 months after discharge
Title
Postoperative continence
Time Frame
Measured via survey up to 18 months after discharge
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Wallen, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Hospital
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Using Virtual Reality (VR) Models for Robotic Prostatectomy - UNC
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