NCT03489187CompletedNot Applicable
Visualase Visualization Database (VIVID-1)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- MedtronicNeuro
- Enrollment
- 183
- Locations
- 7
- Primary Endpoint
- Image assessment
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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
- •Patient correlating with the de-identified data set to be collected is enrolled in the Medtronic SLATE trial
Outcomes
Primary Outcomes
Image assessment
Time Frame: During the Procedure
Identify pathologies and tissue types prescribed Visualse Thermal Therapy
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (7)
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