Prostate CancerNCT03870269
Using Virtual Reality (VR) Models for Robotic Prostatectomy - UNC
A study testing Ceevra Reveal in people with Prostate Cancer, run by Ceevra, Inc. at 1 site 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 to 100 years, 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
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 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 to 100 years
- 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
1 site in 1 country.
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
VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Subjects whose surgeon will be viewing VR models in addition to the source CT/MR image in connection with the case. Receives: Device: Ceevra Reveal |
| Control Arm | No intervention | Subjects whose surgeon will only be viewing CT/MR images in connection with the case. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total operative time
Measured: During procedure, not to exceed 12 hours
Secondary outcomes (11)
Blood loss (measured in cubic centimeters)
Measured: Measured at end of procedure, not to exceed 12 hours
Intraoperative conversion from robotic assisted laparoscopic procedure to open procedure
Measured: During procedure, not to exceed 12 hours
Intraoperative complication
Measured: During procedure, not to exceed 12 hours
Patient hospital stay
Measured: Measured at time of patient discharge, up to 10 days
Positive tumor margin (assessed via standard post-operative biopsy)
Measured: Measured 1-2 weeks after discharge
Postoperative Gleason Score
Measured: Measured up to 3 months after discharge
Postoperative oncologic stage (T stage)
Measured: Measured up to 3 months after discharge
Readmission
Measured: Measured up to 6 months after discharge
Postoperative prostate-specific antigen (PSA)
Measured: Measured up to 12 months after disccharge
Postoperative erectile function
Measured: Measured via survey up to 18 months after discharge
Postoperative continence
Measured: Measured via survey up to 18 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start25 Feb 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.
- 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ceevra, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Wallen, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870269
- Sponsor's protocol ID
- 17-0904RP
- Status last verified
- Aug 2024
- First submitted
- 8 Mar 2019
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Virtual Reality (VR) Models for Robotic Prostatectomy - UNC
- ClinicalTrials.gov ID
- NCT03870269
- Acronym / sponsor ID
- 17-0904RP
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ceevra, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 12 Mar 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 |
|---|---|---|
| Intervention Arm | Experimental | Device: Ceevra RevealSubjects whose surgeon will be viewing VR models in addition to the source CT/MR image in connection with the case. |
| Control Arm | No intervention | –Subjects whose surgeon will only be viewing CT/MR images in connection with the case. |
Who may qualify
- Ages
- 18 to 100 years
- 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 RevealVR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image. | Device | Intervention Arm |
Primary outcome
Total operative time
Time frame: During procedure, not to exceed 12 hours
11 secondary outcomes
Blood loss (measured in cubic centimeters)
Time frame: Measured at end of procedure, not to exceed 12 hours
Intraoperative conversion from robotic assisted laparoscopic procedure to open procedure
Time frame: During procedure, not to exceed 12 hours
Intraoperative complication
Time frame: During procedure, not to exceed 12 hours
Patient hospital stay
Time frame: Measured at time of patient discharge, up to 10 days
Positive tumor margin (assessed via standard post-operative biopsy)
Time frame: Measured 1-2 weeks after discharge
Postoperative Gleason Score
Time frame: Measured up to 3 months after discharge
Postoperative oncologic stage (T stage)
Time frame: Measured up to 3 months after discharge
Readmission
Time frame: Measured up to 6 months after discharge
Postoperative prostate-specific antigen (PSA)
Time frame: Measured up to 12 months after disccharge
Postoperative erectile function
Time frame: Measured via survey up to 18 months after discharge
Postoperative continence
Time frame: Measured via survey up to 18 months after discharge
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 28 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Eric Wallen, MD principal investigator
University of North Carolina, Chapel Hill
1 site 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 1 site 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 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Total operative time (time frame: During procedure, not to exceed 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2024.