Using Virtual Reality (VR) Models for Robotic Prostatectomy

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Device: Ceevra Reveal

• Registration Number: NCT03943368
• Lead Sponsor: Ceevra, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-09
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Intervention Arm	Ceevra Reveal	Subjects whose surgeon will be viewing Digital 3D models in addition to the source MR image and biopsy results in connection with the case.

Primary Outcome Measures

Name	Time	Method
Postoperative PSA	Up to 24 months	PSA blood test measured at threshold of 0.1 at 3-6 and 18-24 months

Secondary Outcome Measures

Name	Time	Method
Androgen Deprivation or Radiation Therapy	Up to 24 months postoperatively	Any occurrence of salvage or adjuvant therapy post surgery
Postoperative Urinary Function	Up to 24 months postoperatively	Bladder neck sparing immediately postoperatively, pads per day at 3-6 and 18-24 months
Surgical Margin Status	Immediately postoperatively	Defined as positive or negative surgical margin
Postoperative Erectile Function	Up to 24 months postoperatively	Nerve sparing immediately postoperatively, SHIM score at 3-6 and 18-24 months

Trial Locations

Locations (6)

UCLA Urology; 🇺🇸 Los Angeles, California, United States

Swedish Urology Group; 🇺🇸 Seattle, Washington, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States

UC Irvine; 🇺🇸 Orange, California, United States

Mount Sinai Health System; 🇺🇸 New York, New York, United States