Visualase Visualization Database (VIVID-1)
VIVID-1
1 other identifier
observational
183
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2018
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2018
CompletedStudy Start
First participant enrolled
March 5, 2018
CompletedFirst Posted
Study publicly available on registry
April 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2022
CompletedMay 4, 2022
May 1, 2022
4.2 years
January 18, 2018
May 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Image assessment
Identify pathologies and tissue types prescribed Visualse Thermal Therapy
During the Procedure
Study Arms (1)
VTTS as standard of care
VTTS as standard of care.
Interventions
Patients who have previously received treatment with VTTS when used as intended.
Eligibility Criteria
Patients who have previously received treatment with VTTS when used as intended.
You may qualify if:
- \. 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedtronicNeurolead
Study Sites (7)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2018
First Posted
April 5, 2018
Study Start
March 5, 2018
Primary Completion
April 29, 2022
Study Completion
April 29, 2022
Last Updated
May 4, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share