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OpenTrials
Completed

NCT Number: NCT03943368

Using Virtual Reality (VR) Models for Robotic Prostatectomy

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Urology, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ceevra Reveal

Device

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

Primary outcomes

  1. 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

  1. Surgical Margin Status

    Time frame: Immediately postoperatively

    Defined as positive or negative surgical margin

  2. Androgen Deprivation or Radiation Therapy

    Time frame: Up to 24 months postoperatively

    Any occurrence of salvage or adjuvant therapy post surgery

  3. Postoperative Erectile Function

    Time frame: Up to 24 months postoperatively

    Nerve sparing immediately postoperatively, SHIM score at 3-6 and 18-24 months

  4. Postoperative Urinary Function

    Time frame: Up to 24 months postoperatively

    Bladder neck sparing immediately postoperatively, pads per day at 3-6 and 18-24 months

Sponsors and collaborators

Lead sponsor

Ceevra, Inc.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 9, 2019
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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