Using Virtual Reality (VR) Models for Robotic Prostatectomy

Prostate Cancer Clinical Trial

Official title:

Using Virtual Reality (VR) Models for Robotic Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03943368
• Other study ID #: 20171006RP
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: September 30, 2023

Study information

• Verified date: June 2024
• Source: Ceevra, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Ceevra Reveal
3D Digital models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source MR image.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ceevra, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative PSA	PSA blood test measured at threshold of 0.1 at 3-6 and 18-24 months	Up to 24 months
Secondary	Surgical Margin Status	Defined as positive or negative surgical margin	Immediately postoperatively
Secondary	Androgen Deprivation or Radiation Therapy	Any occurrence of salvage or adjuvant therapy post surgery	Up to 24 months postoperatively
Secondary	Postoperative Erectile Function	Nerve sparing immediately postoperatively, SHIM score at 3-6 and 18-24 months	Up to 24 months postoperatively
Secondary	Postoperative Urinary Function	Bladder neck sparing immediately postoperatively, pads per day at 3-6 and 18-24 months	Up to 24 months postoperatively