Prostate CancerNCT03943368
Using Virtual Reality (VR) Models for Robotic Prostatectomy
A study testing Ceevra Reveal in people with Prostate Cancer, run by Ceevra, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Ceevra Reveal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Jan 2019to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is undergoing robotic prostatectomy being performed by participating surgeon
- Patient is willing to be randomized between intervention and control arms
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Mayo Clinic Florida
Jacksonville, Florida, 32224
UCLA Urology
Los Angeles, California, 90094
Mount Sinai Health System
New York, New York, 10029
UC Irvine
Orange, California, 92868
Swedish Urology Group
Seattle, Washington, 98104
Swedish Medical Center
Seattle, Washington, 98122
About this study
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.
- Conditions
- Prostate Cancer
- Being tested
- Ceevra Reveal
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceevra RevealDevice
3D Digital models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source MR image.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention Arm | Experimental | Subjects whose surgeon will be viewing Digital 3D models in addition to the source MR image and biopsy results in connection with the case. Receives: Device: Ceevra Reveal |
| Control Arm | No intervention | Subjects whose surgeon will only be viewing MR images in connection with the case. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative PSA
PSA blood test measured at threshold of 0.1 at 3-6 and 18-24 months
Measured: Up to 24 months
Secondary outcomes (4)
Surgical Margin Status
Defined as positive or negative surgical margin
Measured: Immediately postoperatively
Androgen Deprivation or Radiation Therapy
Any occurrence of salvage or adjuvant therapy post surgery
Measured: Up to 24 months postoperatively
Postoperative Erectile Function
Nerve sparing immediately postoperatively, SHIM score at 3-6 and 18-24 months
Measured: Up to 24 months postoperatively
Postoperative Urinary Function
Bladder neck sparing immediately postoperatively, pads per day at 3-6 and 18-24 months
Measured: Up to 24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start1 Jan 2019
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ceevra, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Porter, MD, Principal investigator, Swedish Medical CenterRaymond Pak, MD, Principal investigator, Mayo ClinicThomas Ahlering, MD, Principal investigator, UC IrvineRobert Reiter, MD, Principal investigator, UCLA UrologyKetan Badani, MD, Principal investigator, Mount Sinai Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943368
- Sponsor's protocol ID
- 20171006RP
- Status last verified
- Jun 2024
- First submitted
- 7 May 2019
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Shirk JD, Reiter RE, Wallen EM, Pak RW, Ahlering T, Badani KK, Porter JR. Trifecta Outcomes After Use of 3-Dimensional Digital Models for Planning of Robotic Prostatectomy: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2434143. doi: 10.1001/jamanetworkopen.2024.34143.
PubMed 39283633Shirk JD, Reiter R, Wallen EM, Pak R, Ahlering T, Badani KK, Porter JR. Effect of 3-Dimensional, Virtual Reality Models for Surgical Planning of Robotic Prostatectomy on Trifecta Outcomes: A Randomized Clinical Trial. J Urol. 2022 Sep;208(3):618-625. doi: 10.1097/JU.0000000000002719. Epub 2022 Jul 18.
PubMed 35848770
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Virtual Reality (VR) Models for Robotic Prostatectomy
- ClinicalTrials.gov ID
- NCT03943368
- Acronym / sponsor ID
- 20171006RP
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Ceevra, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention Arm | Experimental | Device: Ceevra RevealSubjects whose surgeon will be viewing Digital 3D models in addition to the source MR image and biopsy results in connection with the case. |
| Control Arm | No intervention | –Subjects whose surgeon will only be viewing MR images in connection with the case. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is undergoing robotic prostatectomy being performed by participating surgeon
- Patient is willing to be randomized between intervention and control arms
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceevra Reveal3D Digital models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source MR image. | Device | Experimental: Intervention Arm |
Primary outcome
Postoperative PSA
Time frame: Up to 24 months
PSA blood test measured at threshold of 0.1 at 3-6 and 18-24 months
4 secondary outcomes
Surgical Margin Status
Time frame: Immediately postoperatively
Androgen Deprivation or Radiation Therapy
Time frame: Up to 24 months postoperatively
Postoperative Erectile Function
Time frame: Up to 24 months postoperatively
Postoperative Urinary Function
Time frame: Up to 24 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 39283633Shirk JD, Reiter RE, Wallen EM, Pak RW, Ahlering T, Badani KK, Porter JR. Trifecta Outcomes After Use of 3-Dimensional Digital Models for Planning of Robotic Prostatectomy: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2434143. doi: 10.1001/jamanetworkopen.2024.34143.
- Derived from this study: PubMed 35848770Shirk JD, Reiter R, Wallen EM, Pak R, Ahlering T, Badani KK, Porter JR. Effect of 3-Dimensional, Virtual Reality Models for Surgical Planning of Robotic Prostatectomy on Trifecta Outcomes: A Randomized Clinical Trial. J Urol. 2022 Sep;208(3):618-625. doi: 10.1097/JU.0000000000002719. Epub 2022 Jul 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Porter, MD principal investigator
Swedish Medical Center
Raymond Pak, MD principal investigator
Mayo Clinic
Thomas Ahlering, MD principal investigator
UC Irvine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ceevra Reveal in people with Prostate Cancer, run by Ceevra, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative PSA (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03943368, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024; AzTrials last refreshed its copy on 28 Oct 2026.