CLOTBUST Hands-Free: A Phase I/II Pilot Safety Trial "CLOTBUST-HF"

Completed

Phase 1/2 Results

Summary of Purpose

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.

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 17 May 2016.

1 Dec 2008 8 Nov 2010 1 Oct 2013 1 Oct 2013 1 May 2016 27 Jan 2014
Start Date First Received 1st Completion Completion Verification Results

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Contacts

  • 1st Contact: Loren F. Shen, RN UT Medical School-Houston Recruiting Houston, Texas, United States, 77030 Phone: 713-500-7084 Email: loren.shem@uth.tmc.edu 2nd Contact: University of Alabama Birmingham Not yet recruiting Birmingham, Alabama, United States, 35233 Contact: April Sisson, RN Phone: 205-975-7571 Email: asisson@uab.edu

    loren.shem@uth.tmc.edu