Using Virtual Reality (VR) Models for Preoperative Planning - University of Tennessee

Using Virtual Reality (VR) Models for Preoperative Planning - University of Tennessee

Sponsors

Lead Sponsor: Ceevra, Inc.

Source 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

Overall Status Completed
Start Date 2018-04-11
Completion Date 2019-03-18
Primary Completion Date 2019-02-28
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Hilum dissection time During procedure, not to exceed 12 hours
Tumor localization time During procedure, not to exceed 12 hours
Tumor resection time During procedure, not to exceed 12 hours
Reconstruction time During procedure, not to exceed 12 hours
Total operative time During procedure, not to exceed 12 hours
Secondary Outcome
Measure Time Frame
Blood loss (measured in cubic centimeters) Measured at end of procedure, not to exceed 12 hours
Clamp time Measured at end of procedure, not to exceed 12 hours
Intraoperative conversion from robotic assisted laparoscopic procedure to open procedure During procedure, not to exceed 12 hours
Intraoperative conversion from partial nephrectomy to radical nephrectomy During procedure, not to exceed 12 hours
Intraoperative complication During procedure, not to exceed 12 hours
Patient hospital stay Measured at time of patient discharge, up to 10 days
Positive tumor margin (assessed via standard post-operative biopsy) Measured 1-2 weeks after discharge
Post-Op complication Measured up to 6 months after discharge
Readmission Measured up to 6 months after discharge
Enrollment 20
Condition
Intervention

Intervention Type: Device

Intervention Name: Ceevra Reveal

Description: VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image.

Arm Group Label: Intervention Arm

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Wesley White, MD Principal Investigator University of Tennessee Medical Center
Location
Facility: University of Tennessee Medical Center
Location Countries

United States

Verification Date

2019-06-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Intervention Arm

Type: Experimental

Description: Subjects whose surgeon will be viewing VR models in addition to the source CT/MR image in connection with the case.

Label: Control Arm

Type: No Intervention

Description: Subjects whose surgeon will only be viewing CT/MR images in connection with the case.

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News