Using Virtual Reality (VR) Models for Preoperative Planning

• Sponsor: Ceevra, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03334344
• Collaborator: (none)
• Enrollment: 92
• Locations: 6
• Arms: 2
• Actual Duration (Months): 16.8
• Patients Per Site: 15.3
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer; Renal Cell Carcinoma	Device: Ceevra Reveal	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Using Virtual Reality (VR) Models for Preoperative Planning
• Actual Study Start Date: Oct 24, 2017
• Actual Primary Completion Date: Feb 28, 2019
• Actual Study Completion Date: Mar 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Arm Subjects whose surgeon will be viewing VR models in connection with the in addition to the source CT/MR image	Device: Ceevra Reveal; VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image.
No Intervention: Control Arm Subjects whose surgeon will only be viewing CT/MR images in connection with the case

Outcome Measures

Primary Outcome Measures

1. Total Operative Time [During procedure]

Secondary Outcome Measures

1. Blood Loss [Measured at end of procedure]

2. Clamp Time [Measured at end of procedure]

3. Number of Patients With Conversion to Open Surgery [During procedure]

4. Number of Patients With Conversion to Radical Nephrectomy [During procedure]

5. Number of Patients With an Intraoperative Complication [During procedure]

6. Patient Hospital Stay [Measured at time of patient discharge, up to 10 days]

7. Number of Patients With a Positive Surgical Margin [Measured 1-2 weeks after discharge]

   Incomplete removal of tumor as defined by the surgical pathology

8. Post-Op Complication [Measured up to 6 months after discharge]

9. Readmission [Measured up to 6 months after discharge]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	John Wayne Cancer Institute at Providence St. John's Heath Center	Santa Monica	California	United States	90404
2	Mayo Clinic Florida	Jacksonville	Florida	United States	32224
3	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
4	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina	United States	27514
5	University of Tennessee	Knoxville	Tennessee	United States	37920
6	Swedish Urology Group	Seattle	Washington	United States	98104

Sponsors and Collaborators

• Ceevra, Inc.

Investigators

• Study Director: Russ Yoshinaka, BS, JD, Sponsor GmbH

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 12, 2017

More Information

Publications

None provided.

• Responsible Party: Ceevra, Inc.
• ClinicalTrials.gov Identifier: NCT03334344
• Other Study ID Numbers: 20171006; NCT03421418; NCT03534206; NCT03542565; NCT03556943; NCT03666104
• First Posted: Nov 7, 2017
• Last Update Posted: Aug 11, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Carcinoma, Renal Cell; Kidney Neoplasms

Study Results

Participant Flow

Arm/Group Title	Intervention Arm	Control Arm
Arm/Group Description	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.	Subjects whose surgeon will only be viewing CT/MR images in connection with the case
Period Title: Overall Study
STARTED	44	48
COMPLETED	44	48
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intervention Arm	Control Arm	Total
Arm/Group Description	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.	Subjects whose surgeon will only be viewing CT/MR images in connection with the case	Total of all reporting groups
Overall Participants	44	48	92
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.6 (9.7)	57.6 (9.7)	60.9 (11.6)
Sex: Female, Male (Count of Participants)
Female	15 34.1%	19 39.6%	34 37%
Male	29 65.9%	29 60.4%	58 63%
Race/Ethnicity, Customized (Count of Participants)
White	36 81.8%	38 79.2%	74 80.4%
Non-White	8 18.2%	10 20.8%	18 19.6%
Region of Enrollment (participants) [Number]
United States	44 100%	48 100%	92 100%

Outcome Measures

1. Primary Outcome

Title	Total Operative Time
Time Frame	During procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Arm	Control Arm
Arm/Group Description	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.	Subjects whose surgeon will only be viewing CT/MR images in connection with the case
Measure Participants	44	48
Median (Inter-Quartile Range) [minutes]	163	173.5

2. Secondary Outcome

Title	Blood Loss
Time Frame	Measured at end of procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Arm	Control Arm
Arm/Group Description	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.	Subjects whose surgeon will only be viewing CT/MR images in connection with the case
Measure Participants	44	48
Mean (Standard Deviation) [cc]	124.5 (90.5)	145.7 (140.4)

3. Secondary Outcome

Title	Clamp Time
Time Frame	Measured at end of procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Arm	Control Arm
Arm/Group Description	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.	Subjects whose surgeon will only be viewing CT/MR images in connection with the case
Measure Participants	44	48
Median (Inter-Quartile Range) [minutes]	18	18

4. Secondary Outcome

Title	Number of Patients With Conversion to Open Surgery
Time Frame	During procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Arm	Control Arm
Arm/Group Description	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.	Subjects whose surgeon will only be viewing CT/MR images in connection with the case
Measure Participants	44	48
Count of Participants [Participants]	0 0%	0 0%

5. Secondary Outcome

Title	Number of Patients With Conversion to Radical Nephrectomy
Time Frame	During procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Arm	Control Arm
Arm/Group Description	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.	Subjects whose surgeon will only be viewing CT/MR images in connection with the case
Measure Participants	44	48
Count of Participants [Participants]	3 6.8%	3 6.3%

6. Secondary Outcome

Title	Number of Patients With an Intraoperative Complication
Time Frame	During procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Arm	Control Arm
Arm/Group Description	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.	Subjects whose surgeon will only be viewing CT/MR images in connection with the case
Measure Participants	44	48
Count of Participants [Participants]	1 2.3%	0 0%

7. Secondary Outcome

Title	Patient Hospital Stay
Time Frame	Measured at time of patient discharge, up to 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Arm	Control Arm
Arm/Group Description	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.	Subjects whose surgeon will only be viewing CT/MR images in connection with the case
Measure Participants	44	48
Mean (Standard Deviation) [Days]	1.5 (0.8)	1.64 (0.9)

8. Secondary Outcome

Title	Number of Patients With a Positive Surgical Margin
Description	Incomplete removal of tumor as defined by the surgical pathology
Time Frame	Measured 1-2 weeks after discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Arm	Control Arm
Arm/Group Description	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.	Subjects whose surgeon will only be viewing CT/MR images in connection with the case
Measure Participants	44	48
Count of Participants [Participants]	0 0%	0 0%

9. Secondary Outcome

Title	Post-Op Complication
Time Frame	Measured up to 6 months after discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Arm	Control Arm
Arm/Group Description	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.	Subjects whose surgeon will only be viewing CT/MR images in connection with the case
Measure Participants	44	48
Count of Participants [Participants]	4 9.1%	2 4.2%

10. Secondary Outcome

Title	Readmission
Time Frame	Measured up to 6 months after discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Arm	Control Arm
Arm/Group Description	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.	Subjects whose surgeon will only be viewing CT/MR images in connection with the case
Measure Participants	44	48
Count of Participants [Participants]	4 9.1%	2 4.2%

Adverse Events

Time Frame	17 months
Arm/Group Title	Intervention Arm		Control Arm
Arm/Group Description	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.		Subjects whose surgeon will only be viewing CT/MR images in connection with the case
All Cause Mortality
	Intervention Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/48 (0%)
Serious Adverse Events
	Intervention Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/48 (0%)
Other (Not Including Serious) Adverse Events
	Intervention Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/48 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.