Using Virtual Reality (VR) Models for Robotic Prostatectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2023-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental: Intervention Arm

Subjects whose surgeon will be viewing Digital 3D models in addition to the source MR image and biopsy results in connection with the case.

Group Type EXPERIMENTAL

Ceevra Reveal

Intervention Type DEVICE

3D Digital models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source MR image.

Control Arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ceevra Reveal

3D Digital models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source MR image.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No