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Clinical Trials/NCT03943368
NCT03943368
Completed
Not Applicable

Using Virtual Reality (VR) Models for Robotic Prostatectomy

Ceevra, Inc.6 sites in 1 country92 target enrollmentJanuary 1, 2019
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ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Ceevra, Inc.
Enrollment
92
Locations
6
Primary Endpoint
Postoperative PSA
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar 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
January 1, 2019
End Date
September 30, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

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

Postoperative PSA

Time Frame: Up to 24 months

PSA blood test measured at threshold of 0.1 at 3-6 and 18-24 months

Secondary Outcomes

  • Androgen Deprivation or Radiation Therapy(Up to 24 months postoperatively)
  • Postoperative Urinary Function(Up to 24 months postoperatively)
  • Surgical Margin Status(Immediately postoperatively)
  • Postoperative Erectile Function(Up to 24 months postoperatively)

Study Sites (6)

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