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

Qualifiers

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 design

Treatments tested in this trial

  • GammaTile

Treatment groups

600 Participants
are divided into 1 treatment group

Locations

54
Arizona
HonorHeath Scottsdale Osborn Medical Center85027, Phoenix United States
Arkansas
University of Arkansas Medical Center72205, Little Rock United States
California
Eden Medical Center94546, Castro Valley United States
UCSD Moores Cancer Center92093, La Jolla United States

Sponsors and collaborators

GT Medical Technologies, Inc.

Lead sponsor