Using Virtual Reality (VR) Models for Preoperative Planning

Renal Cell Carcinoma Clinical Trial

Official title:

Using Virtual Reality (VR) Models for Preoperative Planning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03334344
• Other study ID #: 20171006
• Status: Completed
• Phase: N/A
• Start date: October 24, 2017
• Est. completion date: March 18, 2019

Study information

• Verified date: July 2022
• Source: Ceevra, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT03421418
• NCT03534206
• NCT03542565
• NCT03556943
• NCT03666104

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: March 18, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Renal Cell Carcinoma

Intervention

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.

Locations

Country	Name	City	State
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	University of Tennessee	Knoxville	Tennessee
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	John Wayne Cancer Institute at Providence St. John's Heath Center	Santa Monica	California
United States	Swedish Urology Group	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Ceevra, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Operative Time		During procedure
Secondary	Blood Loss		Measured at end of procedure
Secondary	Clamp Time		Measured at end of procedure
Secondary	Number of Patients With Conversion to Open Surgery		During procedure
Secondary	Number of Patients With Conversion to Radical Nephrectomy		During procedure
Secondary	Number of Patients With an Intraoperative Complication		During procedure
Secondary	Patient Hospital Stay		Measured at time of patient discharge, up to 10 days
Secondary	Number of Patients With a Positive Surgical Margin	Incomplete removal of tumor as defined by the surgical pathology	Measured 1-2 weeks after discharge
Secondary	Post-Op Complication		Measured up to 6 months after discharge
Secondary	Readmission		Measured up to 6 months after discharge