Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)

Completed

Phase 3 Results

Summary of Purpose

The purpose of this pivotal study is to demonstrate safety and effectiveness of the NeuroThera® Laser System (referred to hereafter as NTS) in the treatment of Subjects diagnosed with acute ischemic stroke. The initiation of NTS treatment must be feasible for each Subject within 24 hours of stroke onset.

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 7 June 2011.

1 Dec 2006 5 Jan 2007 1 Jul 2008 1 Jul 2008 1 Jun 2011 Unavailable
Start Date First Received 1st Completion Completion Verification Results

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Contacts

  • Sanja Ilic, MD, MSc, RAC phone: 760-496-3700 ext 106

    silic@photothera.com