Protocol CP-01 Study of SonoLysis Headframe Version 4c Oct 18 2013
Research type
Research Study
Full title
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of the Combined Lysis of Thrombus with Ultrasound and Systemic Tissue Plasminogen Activator (tPA) for Emergent Revascularization (CLOTBUST-ER) in Acute Ischemic Stroke.
IRAS ID
148403
Contact name
Keith Muir
Contact email
Sponsor organisation
Cerevast Therapeutics, Inc.
Clinicaltrials.gov Identifier
Research summary
This is a randomized, placebo-controlled, double-blind phase 3 clinical study to evaluate the safety and effectiveness of ultrasound (sound waves which are, for example, used medically to create images of organs) using a specially designed headset (“SonoLysis Headframe“) as an add-on treatment in patients with an acute stroke caused by a blockage in a major blood vessel in the brain who are given “clot-busting“ thrombolytic drug treatment with the standard drug, tissue plasminogen activator (tPA). Each subject will be randomized (like tossing a coin) to active or non-active ultrasound for a period of two hours during the time when tPA is being given intravenously (within a vein). The headframe sits like a headband around the subject’s head and is mostly constructed of soft plastic that causes minimal discomfort. The study will be conducted in hospitals where tPA is used routinely to treat stroke. The subjects will be actively observed using standard tests for stroke patients for 7 days or until hospital discharge, whichever is first, and will be reviewed on day 90 for a final physical examination and assessment to determine their recovery level.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
14/YH/0049
Date of REC Opinion
25 Mar 2014
REC opinion
Further Information Favourable Opinion