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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03542565
Other study ID # 20171006JWCI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 30, 2018
Est. completion date March 18, 2019

Study information

Verified date June 2019
Source Ceevra, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date March 18, 2019
Est. primary completion date February 28, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
United States John Wayne Cancer Institute at Providence St. John's Health Center Santa Monica California

Sponsors (1)

Lead Sponsor Collaborator
Ceevra, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hilum dissection time During procedure, not to exceed 12 hours
Primary Tumor localization time During procedure, not to exceed 12 hours
Primary Tumor resection time During procedure, not to exceed 12 hours
Primary Reconstruction time During procedure, not to exceed 12 hours
Primary Total operative time During procedure, not to exceed 12 hours
Secondary Blood loss (measured in cubic centimeters) Measured at end of procedure, not to exceed 12 hours
Secondary Clamp time Measured at end of procedure, not to exceed 12 hours
Secondary 8. Intraoperative conversion from robotic assisted laparoscopic procedure to open procedure During procedure, not to exceed 12 hours
Secondary Intraoperative conversion from partial nephrectomy to radical nephrectomy During procedure, not to exceed 12 hours
Secondary Intraoperative complication During procedure, not to exceed 12 hours
Secondary Patient hospital stay Measured at time of patient discharge, up to 10 days
Secondary Positive tumor margin (assessed via standard post-operative biopsy) Measured 1-2 weeks after discharge
Secondary Post-Op complication Measured up to 6 months after discharge
Secondary Readmission Measured up to 6 months after discharge
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