Kidney Cancer, Renal Cell Carcinoma
Conditions
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 partial nephrectomy) and improved patient care.
Interventions
DEVICECeevra Reveal
VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image.
Sponsors
Ceevra, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Subject is undergoing robotic partial nephrectomy being performed by participating surgeon * Subject is willing to be randomized between intervention and control arms
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Operative Time | During procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clamp Time | Measured at end of procedure | — |
| Number of Patients With Conversion to Open Surgery | During procedure | — |
| Number of Patients With Conversion to Radical Nephrectomy | During procedure | — |
| Number of Patients With an Intraoperative Complication | During procedure | — |
| Blood Loss | Measured at end of procedure | — |
| Number of Patients With a Positive Surgical Margin | Measured 1-2 weeks after discharge | Incomplete removal of tumor as defined by the surgical pathology |
| Post-Op Complication | Measured up to 6 months after discharge | — |
| Readmission | Measured up to 6 months after discharge | — |
| Patient Hospital Stay | Measured at time of patient discharge, up to 10 days | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 44 |
| Control Arm Subjects whose surgeon will only be viewing CT/MR images in connection with the case | 48 |
| Total | 92 |
Baseline characteristics
| Characteristic | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Age, Continuous | 64.6 years STANDARD_DEVIATION 9.7 | 57.6 years STANDARD_DEVIATION 9.7 | 60.9 years STANDARD_DEVIATION 11.6 |
| Race/Ethnicity, Customized Non-White | 8 Participants | 10 Participants | 18 Participants |
| Race/Ethnicity, Customized White | 36 Participants | 38 Participants | 74 Participants |
| Region of Enrollment United States | 44 participants | 48 participants | 92 participants |
| Sex: Female, Male Female | 15 Participants | 19 Participants | 34 Participants |
| Sex: Female, Male Male | 29 Participants | 29 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 48 |
| other Total, other adverse events | 0 / 44 | 0 / 48 |
| serious Total, serious adverse events | 0 / 44 | 0 / 48 |
Outcome results
Primary
Total Operative Time
Time frame: During procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Arm | Total Operative Time | 163 minutes |
| Control Arm | Total Operative Time | 173.5 minutes |
Secondary
Blood Loss
Time frame: Measured at end of procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Blood Loss | 124.5 cc | Standard Deviation 90.5 |
| Control Arm | Blood Loss | 145.7 cc | Standard Deviation 140.4 |
Secondary
Clamp Time
Time frame: Measured at end of procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Arm | Clamp Time | 18 minutes |
| Control Arm | Clamp Time | 18 minutes |
Secondary
Number of Patients With an Intraoperative Complication
Time frame: During procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Number of Patients With an Intraoperative Complication | 1 Participants |
| Control Arm | Number of Patients With an Intraoperative Complication | 0 Participants |
Secondary
Number of Patients With a Positive Surgical Margin
Incomplete removal of tumor as defined by the surgical pathology
Time frame: Measured 1-2 weeks after discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Number of Patients With a Positive Surgical Margin | 0 Participants |
| Control Arm | Number of Patients With a Positive Surgical Margin | 0 Participants |
Secondary
Number of Patients With Conversion to Open Surgery
Time frame: During procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Number of Patients With Conversion to Open Surgery | 0 Participants |
| Control Arm | Number of Patients With Conversion to Open Surgery | 0 Participants |
Secondary
Number of Patients With Conversion to Radical Nephrectomy
Time frame: During procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Number of Patients With Conversion to Radical Nephrectomy | 3 Participants |
| Control Arm | Number of Patients With Conversion to Radical Nephrectomy | 3 Participants |
Secondary
Patient Hospital Stay
Time frame: Measured at time of patient discharge, up to 10 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Patient Hospital Stay | 1.5 Days | Standard Deviation 0.8 |
| Control Arm | Patient Hospital Stay | 1.64 Days | Standard Deviation 0.9 |
Secondary
Post-Op Complication
Time frame: Measured up to 6 months after discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Post-Op Complication | 4 Participants |
| Control Arm | Post-Op Complication | 2 Participants |
Secondary
Readmission
Time frame: Measured up to 6 months after discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Readmission | 4 Participants |
| Control Arm | Readmission | 2 Participants |