At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Combined Lysis of Thrombus in Brain Ischemia With Transcranial Ultrasound and Systemic T-PA-Hands-Free. A Phase I/II Pilot Safety Trial
In Brief
A Phase 2 clinical trial evaluating 2-MHz transcranial Doppler ultrasound and 2-MHz transcranial Doppler ultrasound insonation for Stroke. Completed, enrolled 35 participants across 2 sites.
Detailed Summary
The purpose of CLOTBUST-HF is to determine the safety of a novel, external Hands-Free transcranial Doppler (TCD) ultrasound system in healthy volunteers and ischemic stroke patients. If found to be safe, the widespread use of operator-independent, ultrasound-enhanced thrombolysis will allow the planning for a large Phase III efficacy trial.
Study Details
Timeline
Interventions
2-hours of hands-free ultrasound will be insonated continuously. A brain MRI with gadolinium will be performed before and after the ultrasound.
2-hours of hands-free ultrasound delivered to in the intracranial vessels.