Visualase Visualization Database (VIVID-1)

MedtronicNeuro183 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

183

Conditions

Epilepsy Tumor Other

Interventions

Visualase Thermal Therapy SystemDEVICE

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (7)

Emory University

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Rutgers

New Brunswick, New Jersey, United States

Baylor College of Medicine

Houston, Texas, United States

Outcomes

Primary Outcomes

Image assessment

Identify pathologies and tissue types prescribed Visualse Thermal Therapy

Time frame: During the Procedure

Data from ClinicalTrials.gov

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