About this trial
The objectives of this registry study are to evaluate real-world clinical outcomes and patient reported outcomes that measure the effectiveness and safety of STaRT.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients who received STaRT (GammaTile) intraoperatively.
Trial design
Cohort
Prospective
Treatments tested in this trial
GammaTile
DeviceSurgically Targeted Radiation Therapy
Treatment groups
Trial outcomes
Primary outcomes
Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects
No contrast enhancement in the area of the surgical bed
Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects
No contrast enhancement in the area of the surgical bed
Overall Survival in High Grade Glioma Subjects
Median duration of survival of subjects following surgical resection of tumor
Sponsors and contacts
Click on the lead sponsor to view all of their trials.