NCT04427384 Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)
| NCT ID | NCT04427384 |
| Status | Recruiting |
| Phase | — |
| Sponsor | GT Medical Technologies, Inc. |
| Condition | Brain Tumor, Recurrent |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2020-09-11 |
| Primary Completion | 2028-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2020-09-11 with a primary completion date of 2028-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles. 2. Willing and able to provide informed consent and to participate in all evaluations. Exclusion Criteria: 1. Inability to undergo pre-operative and post-operative imaging for disease and implant assessment. 2. 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. 3. 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.
Contact & Investigator
Michael A. Garcia, MD, MS
STUDY DIRECTOR
GT Medical Technologies
Frequently Asked Questions
Who can join the NCT04427384 clinical trial?
This trial is open to participants of all sexes, studying Brain Tumor, Recurrent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04427384 currently recruiting?
Yes, NCT04427384 is actively recruiting participants. Contact the research team at mgarcia@gtmedtech.com for enrollment information.
Where is the NCT04427384 trial being conducted?
This trial is being conducted at Phoenix, United States, Little Rock, United States, Castro Valley, United States, La Jolla, United States and 11 additional locations.
Who is sponsoring the NCT04427384 clinical trial?
NCT04427384 is sponsored by GT Medical Technologies, Inc.. The principal investigator is Michael A. Garcia, MD, MS at GT Medical Technologies. The trial plans to enroll 600 participants.