ClinicalTrials.gg
CompletedNCT03489187VIVID-1Updated May 4, 2022

Visualase Visualization Database (VIVID-1)

An observational study in Epilepsy, Tumor and Other, sponsored by MedtronicNeuro. Completed at 7 sites in United States. Per ClinicalTrials.gov, last updated 2022-05-04.

Sponsored by MedtronicNeuro (part of Medtronic) · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
183
Sex
All
01

Study 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.

02

Conditions studied

  • Epilepsy
  • Tumor
  • Other
03

In context

Epilepsy

1,842 studies on the registry are indexed under Epilepsy; 423 are open to participants now.

This study's enrollment of 183 is above the median of 101 across 536 observational studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

MedtronicNeuro is the lead sponsor of 74 studies on the registry; 2 are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
183 participants (actual)
Patient registry
No

Groups and cohorts

  • VTTS as standard of care

    VTTS as standard of care.

    Device: Visualase Thermal Therapy System

Interventions

  • DeviceVisualase Thermal Therapy System

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

    Also known as: VTTS

06

What researchers measure

Primary outcomes

  1. Image assessment

    Identify pathologies and tissue types prescribed Visualse Thermal Therapy

    Time frame: During the Procedure

07

Study locations

7 sites
  • Emory University
    Atlanta, Georgia 30322, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Rutgers
    New Brunswick, New Jersey 08903, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • Seattle Children's
    Seattle, Washington 98101, United States
  • University of Washington Harborview
    Seattle, Washington 98195, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2018 to primary completion in Apr 2022, 49 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 18, 2018
First posted
Apr 5, 2018
StartActual
Mar 5, 2018
Primary completionActual
Apr 29, 2022
CompletionActual
Apr 29, 2022
Last update
May 4, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03489187
Lead sponsor
MedtronicNeuro
Responsible party
Sponsor
First posted
Apr 5, 2018
Start date
Mar 5, 2018
Primary completion
Apr 29, 2022
Completion
Apr 29, 2022
Last update
May 4, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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