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Using Virtual Reality (VR) Models for Preoperative Planning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03334344
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Ceevra, Inc.

Study Description
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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 partial nephrectomy) and improved patient care.

Condition or disease Intervention/treatment Phase
Kidney Cancer Renal Cell Carcinoma Device: Ceevra Reveal Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using Virtual Reality (VR) Models for Preoperative Planning
Actual Study Start Date : October 24, 2017
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : March 18, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Arm
Subjects whose surgeon will be viewing VR models in connection with the in addition to the source CT/MR image
 Device: Ceevra Reveal
VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image.
No Intervention: Control Arm
Subjects whose surgeon will only be viewing CT/MR images in connection with the case


Outcome Measures
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Primary Outcome Measures :
  1. Hilum Dissection Time [ Time Frame: During procedure ]
  2. Tumor Localization Time [ Time Frame: During procedure ]
  3. Tumor Resection Time [ Time Frame: During procedure ]
  4. Reconstruction Time [ Time Frame: During procedure ]
  5. Total Operative Time [ Time Frame: During procedure ]

Secondary Outcome Measures :
  1. Blood Loss [ Time Frame: Measured at end of procedure ]
  2. Clamp Time [ Time Frame: Measured at end of procedure ]
  3. Conversion to Open [ Time Frame: During procedure ]
  4. Conversion to Radical [ Time Frame: During procedure ]
  5. Intraoperative Complication [ Time Frame: During procedure ]
  6. Patient Hospital Stay [ Time Frame: Measured at time of patient discharge, up to 10 days ]
  7. Positive Margin [ Time Frame: Measured 1-2 weeks after discharge ]
  8. Post-Op Complication [ Time Frame: Measured up to 6 months after discharge ]
  9. Readmission [ Time Frame: Measured up to 6 months after discharge ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334344


Locations
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United States, Washington
Swedish Urology Group
Seattle, Washington, United States, 98104
Swedish Medical Center
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Ceevra, Inc.
Investigators
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Study Director: Russ Yoshinaka, BS, JD Sponsor GmbH
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ceevra, Inc.
ClinicalTrials.gov Identifier: NCT03334344    
Obsolete Identifiers: NCT03421418, NCT03534206, NCT03542565, NCT03556943, NCT03666104
Other Study ID Numbers: 20171006
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases