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Clinical Trial 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.


Clinical Trial Description

Patients (N=600) with surgically resected (R) brain tumors of any pathology who have undergone STaRT are eligible. Data collected will include local control, overall survival, QOL, neurocognition, functional decline, and surgical and radiation associated AE's. Data will be collected at 1, 3, 6, 9,12, 18 and 24 months, then every 6 months through 5 years. RESULT: Data will be used to benchmark clinical outcomes of STaRT therapy and allow for comparisons to existing standard-of-care treatments. This will be the first observational registry study of R+STaRT, delivered by Cs-131 sources in permanently implanted resorbable collagen tile carriers. The outcome measures captured will allow for evaluation of the potential risks and benefits of this treatment approach for patients in a real-world setting. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04427384
Study type Observational [Patient Registry]
Source GT Medical Technologies, Inc.
Contact Michael A. Garcia, MD, MS
Phone (833) 662-0044
Email mgarcia@gtmedtech.com
Status Recruiting
Phase
Start date September 11, 2020
Completion date December 31, 2028

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