Visualase Visualization Database (VIVID-1)

Epilepsy Clinical Trial

— VIVID-1  

Official title:

Visualase Visualization Database (VIVID-1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03489187
• Other study ID #: MDT17033NS
• Status: Completed
• Start date: March 5, 2018
• Est. completion date: April 29, 2022

Study information

• Verified date: May 2022
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: April 29, 2022
• Est. primary completion date: April 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Other
• Tumor

Intervention

Device:
• Visualase Thermal Therapy System
Patients who have previously received treatment with VTTS when used as intended.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Chicago	Chicago	Illinois
United States	Baylor College of Medicine	Houston	Texas
United States	MD Anderson Cancer Center	Houston	Texas
United States	Rutgers	New Brunswick	New Jersey
United States	Seattle Children's	Seattle	Washington
United States	University of Washington Harborview	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Image assessment	Identify pathologies and tissue types prescribed Visualse Thermal Therapy	During the Procedure