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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Subjects 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceevra Reveal | Device | VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Operative Time | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Loss | Measured at end of procedure | |
| Clamp Time | Measured at end of procedure | |
| Number of Patients With Conversion to Open Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Russ Yoshinaka, BS, JD | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Wayne Cancer Institute at Providence St. John's Heath Center | Santa Monica | California | 90404 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31532520 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm | Subjects whose surgeon will be viewing VR models in connection with the in addition to the source CT/MR image Ceevra Reveal: VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image. |
| FG001 | Control Arm | Subjects whose surgeon will only be viewing CT/MR images in connection with the case |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm | Subjects whose surgeon will be viewing VR models in connection with the in addition to the source CT/MR image Ceevra Reveal: VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image. |
| BG001 | Control Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Operative Time | Posted | Median | Inter-Quartile Range | minutes | During procedure |
|
|
17 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Arm | Subjects whose surgeon will be viewing VR models in connection with the in addition to the source CT/MR image Ceevra Reveal: VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Russ Yoshinaka | Ceevra | 415-926-9434 | ryoshinaka@ceevra.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 12, 2017 | May 4, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| During procedure |
| Number of Patients With Conversion to Radical Nephrectomy | During procedure |
| Number of Patients With an Intraoperative Complication | During procedure |
| Patient Hospital Stay | 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 1-2 weeks after discharge |
| Post-Op Complication | Measured up to 6 months after discharge |
| Readmission | Measured up to 6 months after discharge |
| Mayo Clinic Florida |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| University of North Carolina, Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
| University of Tennessee | Knoxville | Tennessee | 37920 | United States |
| Swedish Urology Group | Seattle | Washington | 98104 | United States |
Subjects whose surgeon will only be viewing CT/MR images in connection with the case |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Blood Loss | Posted | Mean | Standard Deviation | cc | Measured at end of procedure |
|
|
|
| Secondary | Clamp Time | Posted | Median | Inter-Quartile Range | minutes | Measured at end of procedure |
|
|
|
| Secondary | Number of Patients With Conversion to Open Surgery | Posted | Count of Participants | Participants | During procedure |
|
|
|
| Secondary | Number of Patients With Conversion to Radical Nephrectomy | Posted | Count of Participants | Participants | During procedure |
|
|
|
| Secondary | Number of Patients With an Intraoperative Complication | Posted | Count of Participants | Participants | During procedure |
|
|
|
| Secondary | Patient Hospital Stay | Posted | Mean | Standard Deviation | Days | Measured at time of patient discharge, up to 10 days |
|
|
|
| Secondary | Number of Patients With a Positive Surgical Margin | Incomplete removal of tumor as defined by the surgical pathology | Posted | Count of Participants | Participants | Measured 1-2 weeks after discharge |
|
|
|
| Secondary | Post-Op Complication | Posted | Count of Participants | Participants | Measured up to 6 months after discharge |
|
|
|
| Secondary | Readmission | Posted | Count of Participants | Participants | Measured up to 6 months after discharge |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Control Arm | Subjects whose surgeon will only be viewing CT/MR images in connection with the case | 0 | 48 | 0 | 48 | 0 | 48 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |