Visualase Visualization Database (VIVID-1) (VIVID-1)

The purpose of the VIVID-1 data collection study is to establish a database of clinical images and associated technical files from commercial cases using the Visualase Thermal Therapy System (VTTS). All data collected will be de-identified. No safety or effectiveness assessments will be completed.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Tumor; Other
• Intervention / Treatment: Device: Visualase Thermal Therapy System

• Study Type: Observational
• Enrollment (Actual): 183

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
  • Washington
    • Seattle, Washington, United States, 98101
      • Seattle Children's
    • Seattle, Washington, United States, 98195
      • University of Washington Harborview

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have previously received treatment with VTTS when used as intended.

Description

Inclusion Criteria:

1. Patient correlating with the de-identified data set to be collected received standard of care treatment using the Visualase System prior to the date of site activation.

Exclusion Criteria:

1. Patient correlating with the de-identified data set to be collected is a minor (less than 18 years old, or as defined by local policy) that is not allowed to participate in this type of research project (eg, IRB approval with waiver of consent) per IRB policy
2. Patient correlating with the de-identified data set to be collected is enrolled in the Medtronic SLATE trial

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VTTS as standard of care; VTTS as standard of care.	Device: Visualase Thermal Therapy System; Patients who have previously received treatment with VTTS when used as intended.; Other Names: VTTS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image assessment	Identify pathologies and tissue types prescribed Visualse Thermal Therapy	During the Procedure

Collaborators and Investigators

• Sponsor: MedtronicNeuro

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2018
• Primary Completion (Actual): April 29, 2022
• Study Completion (Actual): April 29, 2022

Study Registration Dates

• First Submitted: January 18, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: MDT17033NS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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