N/A
N=92
Using Virtual Reality (VR) Models for Preoperative Planning
Kidney Cancer · Renal Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03334344 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Total Operative Time — 163; 173.5 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ceevra Reveal (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ceevra, Inc.
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Operative Time |
163; 173.5 | — |
| SECONDARY Blood Loss |
124.5; 145.7 | — |
| SECONDARY Clamp Time |
18; 18 | — |
| SECONDARY Number of Patients With Conversion to Open Surgery |
0; 0 | — |
| SECONDARY Number of Patients With Conversion to Radical Nephrectomy |
3; 3 | — |
| SECONDARY Number of Patients With an Intraoperative Complication |
1; 0 | — |
| SECONDARY Patient Hospital Stay |
1.5; 1.64 | — |
| SECONDARY Number of Patients With a Positive Surgical Margin |
0; 0 | — |
| SECONDARY Post-Op Complication |
4; 2 | — |
| SECONDARY Readmission |
4; 2 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03334344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.