Clinical trial NCT03334344: Using Virtual Reality (VR) Models for Preoperative Planning
Official title: Using Virtual Reality (VR) Models for Preoperative Planning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Cancer
Renal Cell Carcinoma
Lead sponsor: Ceevra, Inc.
Sponsor class: INDUSTRY
First posted: 2017-11-07
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Total Operative Time
timeFrame: During procedure
Secondary outcomes:
measure: Blood Loss
timeFrame: Measured at end of procedure
measure: Clamp Time
timeFrame: Measured at end of procedure
measure: Number of Patients With Conversion to Open Surgery
timeFrame: During procedure
measure: Number of Patients With Conversion to Radical Nephrectomy
timeFrame: During procedure
measure: Number of Patients With an Intraoperative Complication
timeFrame: During procedure
measure: Patient Hospital Stay
timeFrame: Measured at time of patient discharge, up to 10 days
measure: Number of Patients With a Positive Surgical Margin
timeFrame: Measured 1-2 weeks after discharge
measure: Post-Op Complication
timeFrame: Measured up to 6 months after discharge
measure: Readmission
timeFrame: Measured up to 6 months after discharge
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute at Providence St. John's Heath Center
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
city: Knoxville
country: United States
facility: University of Tennessee
state: Tennessee
city: Seattle
country: United States
facility: Swedish Urology Group
state: Washington
Study officials:
affiliation: Sponsor GmbH
name: Russ Yoshinaka, BS, JD
role: STUDY_DIRECTOR
References:
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.