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OpenTrials
Completed

NCT Number: NCT03334344

Using Virtual Reality (VR) Models for Preoperative Planning

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 partial nephrectomy) and improved patient care.

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Key information

Conditions

Kidney Cancer Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Renal Cell Carcinoma Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John Wayne Cancer Institute at Providence St. John's Heath Center, Santa Monica, 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

  • Subject is undergoing robotic partial nephrectomy being performed by participating surgeon
  • Subject is willing to be randomized between intervention and control arms

Exclusion criteria

  • Cases involving subjects who are minors, pregnant or require an authorized representative for informed consent
  • Cases in which the subject has a solitary or horseshoe kidney
  • Cases in which the subject has more than two masses in the applicable kidney
  • Cases involving a bilateral operation

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

Secondary outcomes

  1. Blood Loss

    Time frame: Measured at end of procedure

  2. Clamp Time

    Time frame: Measured at end of procedure

  3. Number of Patients With Conversion to Open Surgery

    Time frame: During procedure

  4. Number of Patients With Conversion to Radical Nephrectomy

    Time frame: During procedure

  5. Number of Patients With an Intraoperative Complication

    Time frame: During procedure

  6. Patient Hospital Stay

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

  7. Number of Patients With a Positive Surgical Margin

    Time frame: Measured 1-2 weeks after discharge

    Incomplete removal of tumor as defined by the surgical pathology

  8. Post-Op Complication

    Time frame: Measured up to 6 months after discharge

  9. Readmission

    Time frame: Measured up to 6 months after discharge

Sponsors and collaborators

Lead sponsor

Ceevra, Inc.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 7, 2017
Registry last updated
Aug 29, 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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