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Using Virtual Reality (VR) Models for Robotic Prostatectomy

Primary Purpose

Prostate Cancer

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ceevra Reveal

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

UCLA Urology
UC Irvine
Mayo Clinic Florida
Mount Sinai Health System
Swedish Urology Group
Swedish Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental: Intervention Arm

Control Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Total operative time

Secondary Outcome Measures

Blood loss (measured in cubic centimeters)

Intraoperative conversion from robotic assisted laparoscopic procedure to open procedure

Intraoperative complication

Patient hospital stay

Positive tumor margin (assessed via standard post-operative biopsy)

Postoperative Gleason Score

Postoperative oncologic stage (T stage)

Readmission

Postoperative prostate-specific antigen (PSA)

Postoperative erectile function

Postoperative continence

Full Information

NCT ID

NCT03943368

First Posted

May 7, 2019

Last Updated

July 19, 2022

Sponsor

Ceevra, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03943368

Brief Title

Using Virtual Reality (VR) Models for Robotic Prostatectomy

Official Title

Using Virtual Reality (VR) Models for Robotic Prostatectomy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 25, 2019 (Actual)

Primary Completion Date

September 30, 2022 (Anticipated)

Study Completion Date

September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ceevra, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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 prostatectomy) and improved patient care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: Intervention Arm

Arm Type

Experimental

Arm Description

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

Arm Title

Control Arm

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Ceevra Reveal

Intervention Description

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

Primary Outcome Measure Information:

Title

Total operative time

Time Frame

During procedure, not to exceed 12 hours

Secondary Outcome Measure Information:

Title

Blood loss (measured in cubic centimeters)

Time Frame

Measured at end of procedure, not to exceed 12 hours

Title

Intraoperative conversion from robotic assisted laparoscopic procedure to open procedure

Time Frame

During procedure, not to exceed 12 hours

Title

Intraoperative complication

Time Frame

During procedure, not to exceed 12 hours

Title

Patient hospital stay

Time Frame

Measured at time of patient discharge, up to 10 days

Title

Positive tumor margin (assessed via standard post-operative biopsy)

Time Frame

Measured 1-2 weeks after discharge

Title

Postoperative Gleason Score

Time Frame

Measured up to 3 months after discharge

Title

Postoperative oncologic stage (T stage)

Time Frame

Measured up to 3 months after discharge

Title

Readmission

Time Frame

Measured up to 6 months after discharge

Title

Postoperative prostate-specific antigen (PSA)

Time Frame

Measured up to 12 months after discharge

Title

Postoperative erectile function

Time Frame

Measured via survey up to 18 months after discharge

Title

Postoperative continence

Time Frame

Measured via survey up to 18 months after discharge

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: