Back to resultsUsing Virtual Reality (VR) Models for Preoperative Planning
Primary Purpose
Kidney Cancer, Renal Cell Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ceevra Reveal
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Cancer
Eligibility 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
Sites / Locations
- John Wayne Cancer Institute at Providence St. John's Heath Center
- Mayo Clinic Florida
- Icahn School of Medicine at Mount Sinai
- University of North Carolina, Chapel Hill
- University of Tennessee
- Swedish Urology Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Arm
Control Arm
Arm Description
Subjects whose surgeon will be viewing VR models in connection with the in addition to the source CT/MR image
Subjects whose surgeon will only be viewing CT/MR images in connection with the case
Outcomes
Primary Outcome Measures
Total Operative Time
Secondary Outcome Measures
Blood Loss
Clamp Time
Number of Patients With Conversion to Open Surgery
Number of Patients With Conversion to Radical Nephrectomy
Number of Patients With an Intraoperative Complication
Patient Hospital Stay
Number of Patients With a Positive Surgical Margin
Incomplete removal of tumor as defined by the surgical pathology
Post-Op Complication
Readmission
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03334344
Brief Title
Using Virtual Reality (VR) Models for Preoperative Planning
Official Title
Using Virtual Reality (VR) Models for Preoperative Planning
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 24, 2017 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
March 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ceevra, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer, Renal Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Subjects whose surgeon will be viewing VR models in connection with the in addition to the source CT/MR image
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Subjects whose surgeon will only be viewing CT/MR images in connection with the case
Intervention Type
Device
Intervention Name(s)
Ceevra Reveal
Intervention Description
VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image.
Primary Outcome Measure Information:
Title
Total Operative Time
Time Frame
During procedure
Secondary Outcome Measure Information:
Title
Blood Loss
Time Frame
Measured at end of procedure
Title
Clamp Time
Time Frame
Measured at end of procedure
Title
Number of Patients With Conversion to Open Surgery
Time Frame
During procedure
Title
Number of Patients With Conversion to Radical Nephrectomy
Time Frame
During procedure
Title
Number of Patients With an Intraoperative Complication
Time Frame
During procedure
Title
Patient Hospital Stay
Time Frame
Measured at time of patient discharge, up to 10 days
Title
Number of Patients With a Positive Surgical Margin
Description
Incomplete removal of tumor as defined by the surgical pathology
Time Frame
Measured 1-2 weeks after discharge
Title
Post-Op Complication
Time Frame
Measured up to 6 months after discharge
Title
Readmission
Time Frame
Measured up to 6 months after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russ Yoshinaka, BS, JD
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
John Wayne Cancer Institute at Providence St. John's Heath Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of North Carolina, Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
University of Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Swedish Urology Group
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31532520
Citation
Shirk JD, Thiel DD, Wallen EM, Linehan JM, White WM, Badani KK, Porter JR. Effect of 3-Dimensional Virtual Reality Models for Surgical Planning of Robotic-Assisted Partial Nephrectomy on Surgical Outcomes: A Randomized Clinical Trial. JAMA Netw Open. 2019 Sep 4;2(9):e1911598. doi: 10.1001/jamanetworkopen.2019.11598.
Results Reference
derived
Learn more about this trial
Using Virtual Reality (VR) Models for Preoperative Planning
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