Visualase Visualization Database (VIVID-1)

Completed

• Conditions: Epilepsy; Tumor; Other
• Interventions: Device: Visualase Thermal Therapy System

• Registration Number: NCT03489187
• Lead Sponsor: MedtronicNeuro

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-18
• Study Start: 2018-03-05
• Study First Submitted QC: 2018-04-03
• Study First Posted: 2018-04-05
• Primary Completion: 2022-04-29
• Study Completion: 2022-04-29
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VTTS as standard of care	Visualase Thermal Therapy System	VTTS as standard of care.

Primary Outcome Measures

Name	Time	Method
Image assessment	During the Procedure	Identify pathologies and tissue types prescribed Visualse Thermal Therapy

Trial Locations

Locations (7)

Rutgers; 🇺🇸 New Brunswick, New Jersey, United States

University of Washington Harborview; 🇺🇸 Seattle, Washington, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Seattle Children's; 🇺🇸 Seattle, Washington, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States