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

C

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

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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