Using Virtual Reality (VR) Models for Preoperative Planning - JWCI

Renal Cell Carcinoma Clinical Trial

Official title:

Using Virtual Reality (VR) Models for Preoperative Planning - JWCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03542565
• Other study ID #: 20171006JWCI
• Status: Completed
• Phase: N/A
• Start date: April 30, 2018
• Est. completion date: March 18, 2019

Study information

• Verified date: June 2019
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• 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	John Wayne Cancer Institute at Providence St. John's Health Center	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Ceevra, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hilum dissection time		During procedure, not to exceed 12 hours
Primary	Tumor localization time		During procedure, not to exceed 12 hours
Primary	Tumor resection time		During procedure, not to exceed 12 hours
Primary	Reconstruction time		During procedure, not to exceed 12 hours
Primary	Total operative time		During procedure, not to exceed 12 hours
Secondary	Blood loss (measured in cubic centimeters)		Measured at end of procedure, not to exceed 12 hours
Secondary	Clamp time		Measured at end of procedure, not to exceed 12 hours
Secondary	8. Intraoperative conversion from robotic assisted laparoscopic procedure to open procedure		During procedure, not to exceed 12 hours
Secondary	Intraoperative conversion from partial nephrectomy to radical nephrectomy		During procedure, not to exceed 12 hours
Secondary	Intraoperative complication		During procedure, not to exceed 12 hours
Secondary	Patient hospital stay		Measured at time of patient discharge, up to 10 days
Secondary	Positive tumor margin (assessed via standard post-operative biopsy)		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