NCT03334344

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2019

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

August 11, 2022

Completed
Last Updated

August 29, 2024

Status Verified

July 1, 2022

Enrollment Period

1.3 years

First QC Date

November 1, 2017

Results QC Date

May 4, 2021

Last Update Submit

August 27, 2024

Conditions

Kidney CancerRenal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Total Operative Time

    During procedure

Secondary Outcomes (9)

  • Blood Loss

    Measured at end of procedure

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Subjects whose surgeon will be viewing VR models in connection with the in addition to the source CT/MR image

Device: Ceevra Reveal

Control Arm

NO INTERVENTION

Subjects whose surgeon will only be viewing CT/MR images in connection with the case

Interventions

Ceevra RevealDEVICE

VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image.

Intervention Arm

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is undergoing robotic partial nephrectomy being performed by participating surgeon
  • Subject is willing to be randomized between intervention and control arms

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

John Wayne Cancer Institute at Providence St. John's Heath Center

Santa Monica, California, 90404, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

University of Tennessee

Knoxville, Tennessee, 37920, United States

Location

Swedish Urology Group

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • Shirk JD, Thiel DD, Wallen EM, Linehan JM, White WM, Badani KK, Porter JR. Effect of 3-Dimensional Virtual Reality Models for Surgical Planning of Robotic-Assisted Partial Nephrectomy on Surgical Outcomes: A Randomized Clinical Trial. JAMA Netw Open. 2019 Sep 4;2(9):e1911598. doi: 10.1001/jamanetworkopen.2019.11598.

    PMID: 31532520DERIVED

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Results Point of Contact

Title
Russ Yoshinaka
Organization
Ceevra
ryoshinaka@ceevra.com
415-926-9434

Study Officials

  • Russ Yoshinaka, BS, JD

    Sponsor GmbH

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2017

First Posted

November 7, 2017

Study Start

October 24, 2017

Primary Completion

February 28, 2019

Study Completion

March 18, 2019

Last Updated

August 29, 2024

Results First Posted

August 11, 2022

Record last verified: 2022-07

Locations

US(6)