Using Virtual Reality (VR) Models for Preoperative Planning

Ceevra

Status: Completed

Conditions: Kidney Cancer; Renal Cell Carcinoma

Treatments: Device: Ceevra Reveal

Study type: Interventional

Funder types: Industry

Identifiers

NCT03334344

20171006

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

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

Treatment:

Device: Ceevra Reveal

Control Arm

No Intervention group

Description:

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

Sponsor of this trial

Lead Sponsor

Ceevra