IRB Study Number 23-620
Status Recruiting
Phase Phase 4
Location Cleveland Clinic Weston Hospital
Institute Neurological Institute
Description
This is a non-interventional research study for patients with a brain tumor who will undergo surgery with GammaTile®. The objective of the study is to evaluate real-world clinical and patient reported outcomes that measure the effectiveness and safety of GammaTiles.
Participants will be followed from pre-procedure (surgery and GammaTile implantation is the procedure) through 5-years post-procedure. Follow up time points are the day of the procedure, 1, 3, 6, 9, 12, 18 and 24 months and every 6 months thereafter up to 5 years.
Inclusion Criteria
- Inability to undergo pre-operative and post-operative imaging for disease and implant assessment.
- Major medical or psychiatric illness, which, in the investigator’s opinion would prevent completion of treatment, ability to complete assessments at the time of enrollment, and/or interfere with follow ups.
- Subjects who, in the investigator’s opinion, are unable to understand the protocol or to give informed consent, have a history of poor cooperation, noncompliance with medical treatment, or difficulty in returning for follow up care. A legally authorized representative may provide consent if the potential subject lacks the capacity to provide consent themselves.
Exclusion Criteria
- Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.
- Willing and able to provide informed consent and to participate in all evaluations.
