Kidney CancerNCT03334344
Using Virtual Reality (VR) Models for Preoperative Planning
A study testing Ceevra Reveal in people with Kidney Cancer and Renal Cell Carcinoma, 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 partial nephrectomy) and improved patient care. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Kidney Cancer, Renal Cell Carcinoma
- 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
- 24 Oct 2017to 18 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is undergoing robotic partial nephrectomy being performed by participating surgeon
- Subject is willing to be randomized between intervention and control arms
Who cannot join
- Cases involving subjects who are minors, pregnant or require an authorized representative for informed consent
- Cases in which the subject has a solitary or horseshoe kidney
- Cases in which the subject has more than two masses in the applicable kidney
- Cases involving a bilateral operation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27514
Mayo Clinic Florida
Jacksonville, Florida, 32224
University of Tennessee
Knoxville, Tennessee, 37920
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
John Wayne Cancer Institute at Providence St. John's Heath Center
Santa Monica, California, 90404
Swedish Urology Group
Seattle, Washington, 98104
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 partial nephrectomy) and improved patient care.
- Conditions
- Kidney Cancer, Renal Cell Carcinoma
- Being tested
- Ceevra Reveal
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
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 connection with the in addition to the source CT/MR image 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
Secondary outcomes (9)
Blood Loss
Measured: Measured at end of procedure
Clamp Time
Measured: Measured at end of procedure
Number of Patients With Conversion to Open Surgery
Measured: During procedure
Number of Patients With Conversion to Radical Nephrectomy
Measured: During procedure
Number of Patients With an Intraoperative Complication
Measured: During procedure
Patient Hospital Stay
Measured: Measured at time of patient discharge, up to 10 days
Number of Patients With a Positive Surgical Margin
Incomplete removal of tumor as defined by the surgical pathology
Measured: Measured 1-2 weeks after discharge
Post-Op Complication
Measured: Measured up to 6 months after discharge
Readmission
Measured: Measured up to 6 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 posted7 Nov 2017
- Study start24 Oct 2017
- Primary completion28 Feb 2019
- Study completion18 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ceevra, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Russ Yoshinaka, BS, JD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334344
- Sponsor's protocol ID
- 20171006
- Status last verified
- Jul 2022
- First submitted
- 1 Nov 2017
- Last updated
- 29 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Shirk JD, Thiel DD, Wallen EM, Linehan JM, White WM, Badani KK, Porter JR. Effect of 3-Dimensional Virtual Reality Models for Surgical Planning of Robotic-Assisted Partial Nephrectomy on Surgical Outcomes: A Randomized Clinical Trial. JAMA Netw Open. 2019 Sep 4;2(9):e1911598. doi: 10.1001/jamanetworkopen.2019.11598.
PubMed 31532520
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Virtual Reality (VR) Models for Preoperative Planning
- ClinicalTrials.gov ID
- NCT03334344
- Acronym / sponsor ID
- 20171006
- Conditions
- Kidney Cancer, Renal Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Ceevra, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 18 Mar 2019 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Posted 11 Aug 2022
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 partial nephrectomy) and improved patient care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: Ceevra RevealSubjects whose surgeon will be viewing VR models in connection with the in addition to the source CT/MR image |
| 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
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject is undergoing robotic partial nephrectomy being performed by participating surgeon
- Subject is willing to be randomized between intervention and control arms
Key exclusion criteria (4 listed)
- Cases involving subjects who are minors, pregnant or require an authorized representative for informed consent
- Cases in which the subject has a solitary or horseshoe kidney
- Cases in which the subject has more than two masses in the applicable kidney
- Cases involving a bilateral operation
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
9 secondary outcomes
Blood Loss
Time frame: Measured at end of procedure
Clamp Time
Time frame: Measured at end of procedure
Number of Patients With Conversion to Open Surgery
Time frame: During procedure
Number of Patients With Conversion to Radical Nephrectomy
Time frame: During procedure
Number of Patients With an Intraoperative Complication
Time frame: During procedure
Patient Hospital Stay
Time frame: Measured at time of patient discharge, up to 10 days
Number of Patients With a Positive Surgical Margin
Time frame: Measured 1-2 weeks after discharge
Post-Op Complication
Time frame: Measured up to 6 months after discharge
Readmission
Time frame: Measured up to 6 months after discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31532520Shirk JD, Thiel DD, Wallen EM, Linehan JM, White WM, Badani KK, Porter JR. Effect of 3-Dimensional Virtual Reality Models for Surgical Planning of Robotic-Assisted Partial Nephrectomy on Surgical Outcomes: A Randomized Clinical Trial. JAMA Netw Open. 2019 Sep 4;2(9):e1911598. doi: 10.1001/jamanetworkopen.2019.11598.
- 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.
Russ Yoshinaka, BS, JD study director
Sponsor GmbH
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 Kidney Cancer and Renal Cell Carcinoma, 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 29 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 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?
Yes. Results are posted in the registry (first posted 11 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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). 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 NCT03334344, which also lists 1 linked publication.
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 29 Aug 2024.