Visualase Visualization Database (VIVID-1)

Medtronic

Status: Completed

Conditions: Epilepsy; Other; Tumor

Treatments: Device: Visualase Thermal Therapy System

Study type: Observational

Funder types: Industry

Identifiers

NCT03489187

MDT17033NS

Details and patient eligibility

About

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.

Enrollment: 183 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

183 participants in 1 patient group

VTTS as standard of care

Description:

VTTS as standard of care.

Treatment:

Device: Visualase Thermal Therapy System