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

Study:

NeuroThera® Effectiveness and Safety Trial - 2 (NEST-2) A Double Blind, Randomized, Controlled, Parallel Group, Multicenter, Pivotal Study to Assess the Safety and Effectiveness of the Treatment of Acute Ischemic Stroke With the NeuroThera® Laser System Within 24 Hours From Stroke Onset

Rationale:

n/a

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.

Study Status: Completed

Recruiting:
n/a

Condition Intervention Phase
Ischemic Stroke Device: NeuroThera® Laser System Phase 3

Verified by PhotoThera, Inc June, 2011

Sponsored by: PhotoThera, Inc
Information provided by: PhotoThera, Inc
ClinicalTrials.gov identifier: NCT00419705

Study Type: Interventional

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

The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States

Justin Zivin, MD, PhD., Study Chair

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.