Using Virtual Reality (VR) Models for Preoperative Planning

Ceevra, Inc.6 sites in 1 country92 target enrollmentOctober 24, 2017

ConditionsKidney Cancer Renal Cell Carcinoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Kidney Cancer
Sponsor: Ceevra, Inc.
Enrollment: 92
Locations: 6
Primary Endpoint: Total Operative Time
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 24, 2017

End Date

March 18, 2019

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ceevra, Inc.

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Total Operative Time

Time Frame: During procedure

Secondary Outcomes

Number of Patients With an Intraoperative Complication(During procedure)
Blood Loss(Measured at end of procedure)
Number of Patients With Conversion to Open Surgery(During procedure)
Clamp Time(Measured at end of procedure)
Number of Patients With Conversion to Radical Nephrectomy(During procedure)
Post-Op Complication(Measured up to 6 months after discharge)
Patient Hospital Stay(Measured at time of patient discharge, up to 10 days)
Number of Patients With a Positive Surgical Margin(Measured 1-2 weeks after discharge)
Readmission(Measured up to 6 months after discharge)