Using Virtual Reality (VR) Models for Robotic Prostatectomy - UNC

Ceevra

Status: Completed

Conditions: Prostate Cancer

Treatments: Device: Ceevra Reveal

Study type: Interventional

Funder types: Industry

Identifiers

NCT03870269

17-0904RP

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 prostatectomy) and improved patient care.

Enrollment: 28 patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is undergoing robotic prostatectomy being performed by participating surgeon
• Patient is willing to be randomized between intervention and control arms

Exclusion criteria

• Patients with prior pelvic radiation
• Patients with prior androgen deprivation therapy
• Patients with prior localized ablative therapy
• Patients with prior TURP or other surgical BPH treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

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

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.