Feasibility Study Comparing the Utility of GLOW800 and FL800 Intraoperative ICG-VA Tools for Intracranial Lesions
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 18-000433
Sponsor Protocol Number: 18-000433
About this study
The purpose of this study is to comparatively evaluate the use of the GLOW800 visualization tool for ICG-VA versus the standard of care visualization tool FL800.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age 18 years or older.
- Diagnosed by preoperative imaging modalities to have an intracranial vascular lesion (aneurysm, arteriovenous malformation or arteriovenous fistula) or a brain tumor with intimate vascular relationships requiring microsurgical intervention.
- Patient or legally authorized representative provides written informed consent to enroll in this study.Translation will be provided as appropriate by each institution.
- Inclusion of women and minorities:Both men and women and members of all ethnic groups are eligible for this trial.
Exclusion Criteria:
- Known allergic reaction to ICG or to any iodides, as ICG contains sodium iodide.
- Children, prisoners, and students.
- Patients who are pregnant.
- Hemodynamic instability or significant impairments in circulation.
- Any uncontrolled systemic condition unrelated to the neurosurgical disease.
- History of psychiatric, additive, or any other disorder that compromises the ability to provide informed consent or comply with study protocols.
- Participation on other clinical trials during the last thirty days.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Bernard Bendok, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available