Using Virtual Reality (VR) Models for Preoperative Planning

Not Applicable

Completed

• Conditions: Kidney Cancer; Renal Cell Carcinoma
• Interventions: Device: Ceevra Reveal

• Registration Number: NCT03334344
• Lead Sponsor: Ceevra, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-24
• Study First Submitted: 2017-11-01
• Study First Submitted QC: 2017-11-02
• Study First Posted: 2017-11-07
• Primary Completion: 2019-02-28
• Study Completion: 2019-03-18
• Results First Submitted: 2021-05-04
• Status Verified: 2022-07
• Results First Submitted QC: 2022-07-19
• Results First Posted: 2022-08-11
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Ceevra Reveal	Subjects whose surgeon will be viewing VR models in connection with the in addition to the source CT/MR image

Primary Outcome Measures

Name	Time	Method
Total Operative Time	During procedure

Secondary Outcome Measures

Name	Time	Method
Readmission	Measured up to 6 months after discharge
Blood Loss	Measured at end of 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
Number of Patients With Conversion to Open Surgery	During procedure
Number of Patients With an Intraoperative Complication	During procedure
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	Incomplete removal of tumor as defined by the surgical pathology

Trial Locations

Locations (6)

John Wayne Cancer Institute at Providence St. John's Heath Center; 🇺🇸 Santa Monica, California, United States

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States

Swedish Urology Group; 🇺🇸 Seattle, Washington, United States

University of Tennessee; 🇺🇸 Knoxville, Tennessee, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

University of North Carolina, Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States