Trial Outcomes & Findings for Using Virtual Reality (VR) Models for Preoperative Planning (NCT NCT03334344)
NCT ID: NCT03334344
Last Updated: 2024-08-29
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
92 participants
Primary outcome timeframe
During procedure
Results posted on
2024-08-29
Participant Flow
Participant milestones
| Measure |
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.
|
Control Arm
Subjects whose surgeon will only be viewing CT/MR images in connection with the case
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
48
|
|
Overall Study
COMPLETED
|
44
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Using Virtual Reality (VR) Models for Preoperative Planning
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=44 Participants
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.
|
Control Arm
n=48 Participants
Subjects whose surgeon will only be viewing CT/MR images in connection with the case
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 9.7 • n=99 Participants
|
57.6 years
STANDARD_DEVIATION 9.7 • n=107 Participants
|
60.9 years
STANDARD_DEVIATION 11.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
36 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=99 Participants
|
48 participants
n=107 Participants
|
92 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: During procedureOutcome measures
| Measure |
Intervention Arm
n=44 Participants
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.
|
Control Arm
n=48 Participants
Subjects whose surgeon will only be viewing CT/MR images in connection with the case
|
|---|---|---|
|
Total Operative Time
|
163 minutes
Interval 146.5 to 200.0
|
173.5 minutes
Interval 148.0 to 199.0
|
SECONDARY outcome
Timeframe: Measured at end of procedureOutcome measures
| Measure |
Intervention Arm
n=44 Participants
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.
|
Control Arm
n=48 Participants
Subjects whose surgeon will only be viewing CT/MR images in connection with the case
|
|---|---|---|
|
Blood Loss
|
124.5 cc
Standard Deviation 90.5
|
145.7 cc
Standard Deviation 140.4
|
SECONDARY outcome
Timeframe: Measured at end of procedureOutcome measures
| Measure |
Intervention Arm
n=44 Participants
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.
|
Control Arm
n=48 Participants
Subjects whose surgeon will only be viewing CT/MR images in connection with the case
|
|---|---|---|
|
Clamp Time
|
18 minutes
Interval 12.0 to 22.0
|
18 minutes
Interval 15.0 to 24.0
|
SECONDARY outcome
Timeframe: During procedureOutcome measures
| Measure |
Intervention Arm
n=44 Participants
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.
|
Control Arm
n=48 Participants
Subjects whose surgeon will only be viewing CT/MR images in connection with the case
|
|---|---|---|
|
Number of Patients With Conversion to Open Surgery
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During procedureOutcome measures
| Measure |
Intervention Arm
n=44 Participants
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.
|
Control Arm
n=48 Participants
Subjects whose surgeon will only be viewing CT/MR images in connection with the case
|
|---|---|---|
|
Number of Patients With Conversion to Radical Nephrectomy
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: During procedureOutcome measures
| Measure |
Intervention Arm
n=44 Participants
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.
|
Control Arm
n=48 Participants
Subjects whose surgeon will only be viewing CT/MR images in connection with the case
|
|---|---|---|
|
Number of Patients With an Intraoperative Complication
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at time of patient discharge, up to 10 daysOutcome measures
| Measure |
Intervention Arm
n=44 Participants
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.
|
Control Arm
n=48 Participants
Subjects whose surgeon will only be viewing CT/MR images in connection with the case
|
|---|---|---|
|
Patient Hospital Stay
|
1.5 Days
Standard Deviation 0.8
|
1.64 Days
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Measured 1-2 weeks after dischargeIncomplete removal of tumor as defined by the surgical pathology
Outcome measures
| Measure |
Intervention Arm
n=44 Participants
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.
|
Control Arm
n=48 Participants
Subjects whose surgeon will only be viewing CT/MR images in connection with the case
|
|---|---|---|
|
Number of Patients With a Positive Surgical Margin
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured up to 6 months after dischargeOutcome measures
| Measure |
Intervention Arm
n=44 Participants
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.
|
Control Arm
n=48 Participants
Subjects whose surgeon will only be viewing CT/MR images in connection with the case
|
|---|---|---|
|
Post-Op Complication
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Measured up to 6 months after dischargeOutcome measures
| Measure |
Intervention Arm
n=44 Participants
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.
|
Control Arm
n=48 Participants
Subjects whose surgeon will only be viewing CT/MR images in connection with the case
|
|---|---|---|
|
Readmission
|
4 Participants
|
2 Participants
|
Adverse Events
Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place