EpilepsyVIVID-1NCT03489187
Visualase Visualization Database (VIVID-1)
An observational study of Epilepsy and Tumor, run by MedtronicNeuro at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Visualase Thermal Therapy System
- Type of treatment
- Medical device
- How many people
- 183 participants
- Where
- 7 sitesUnited States
- Study dates
- 5 Mar 2018to 29 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have previously received treatment with VTTS when used as intended.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Emory University
Atlanta, Georgia, 30322
University of Chicago
Chicago, Illinois, 60637
Baylor College of Medicine
Houston, Texas, 77030
MD Anderson Cancer Center
Houston, Texas, 77030
Rutgers
New Brunswick, New Jersey, 08903
Seattle Children's
Seattle, Washington, 98101
University of Washington Harborview
Seattle, Washington, 98195
About this study
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.
- Being tested
- Visualase Thermal Therapy System
- Medical subject headings
- Epilepsy, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visualase Thermal Therapy SystemDevice
Also called VTTS
Patients who have previously received treatment with VTTS when used as intended.
| Study group | Role | What they receive |
|---|---|---|
| VTTS as standard of care | VTTS as standard of care. Receives: Device: Visualase Thermal Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image assessment
Identify pathologies and tissue types prescribed Visualse Thermal Therapy
Measured: During the Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start5 Mar 2018
- Primary completion29 Apr 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489187
- Sponsor's protocol ID
- MDT17033NS
- Acronym
- VIVID-1
- Status last verified
- May 2022
- First submitted
- 18 Jan 2018
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualase Visualization Database (VIVID-1)
- ClinicalTrials.gov ID
- NCT03489187
- Acronym / sponsor ID
- VIVID-1 / MDT17033NS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VTTS as standard of care | – | Device: Visualase Thermal Therapy SystemVTTS as standard of care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have previously received treatment with VTTS when used as intended.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visualase Thermal Therapy SystemAlso: VTTSPatients who have previously received treatment with VTTS when used as intended. | Device | VTTS as standard of care |
Primary outcome
Image assessment
Time frame: During the Procedure
Identify pathologies and tissue types prescribed Visualse Thermal Therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Tumor, run by MedtronicNeuro at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image assessment (time frame: During the Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.