Visualase Visualization Database (VIVID-1)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

183 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-05

Study Completion Date

2022-04-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Epilepsy Tumor Other

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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VTTS as standard of care

VTTS as standard of care.

Visualase Thermal Therapy System

Intervention Type DEVICE

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

Interventions

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Visualase Thermal Therapy System

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

Intervention Type DEVICE

Other Intervention Names

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VTTS

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No