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OpenTrials
Completed

NCT Number: NCT03870269

Using Virtual Reality (VR) Models for Robotic Prostatectomy - UNC

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–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UNC Hospital

Chapel Hill, North Carolina, 27514, United States

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

VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image.

Primary outcomes

  1. Total operative time

    Time frame: During procedure, not to exceed 12 hours

Secondary outcomes

  1. Blood loss (measured in cubic centimeters)

    Time frame: Measured at end of procedure, not to exceed 12 hours

  2. Intraoperative conversion from robotic assisted laparoscopic procedure to open procedure

    Time frame: During procedure, not to exceed 12 hours

  3. Intraoperative complication

    Time frame: During procedure, not to exceed 12 hours

  4. Patient hospital stay

    Time frame: Measured at time of patient discharge, up to 10 days

  5. Positive tumor margin (assessed via standard post-operative biopsy)

    Time frame: Measured 1-2 weeks after discharge

  6. Postoperative Gleason Score

    Time frame: Measured up to 3 months after discharge

  7. Postoperative oncologic stage (T stage)

    Time frame: Measured up to 3 months after discharge

  8. Readmission

    Time frame: Measured up to 6 months after discharge

  9. Postoperative prostate-specific antigen (PSA)

    Time frame: Measured up to 12 months after disccharge

  10. Postoperative erectile function

    Time frame: Measured via survey up to 18 months after discharge

  11. Postoperative continence

    Time frame: Measured via survey up to 18 months after discharge

Sponsors and collaborators

Lead sponsor

Ceevra, Inc.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2019
Registry last updated
Aug 28, 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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