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NCT01120301 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3)

A Phase 3 study of Acute Ischemic Stroke, sponsored by PhotoThera.

Completed
Registry status
Phase 3
Development phase
1,000
Enrollment target
20
Study locations

NCT01120301 is a Phase 3 study of Acute Ischemic Stroke that has completed, run by PhotoThera. The registered enrollment target is 1,000 participants, above the 312-participant average among 25 other Acute Ischemic Stroke trials with a reported enrollment target (221% higher). The trial reports 20 study locations across 13 states.

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The verdict

NCT01120301, a Phase 3 study of Acute Ischemic Stroke, has completed, sponsored by PhotoThera.

COMPLETED
Registry status
Phase 3
Development phase
1,000 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this pivotal study is to demonstrate safety and efficacy of transcranial laser therapy (TLT) with the NeuroThera® Laser System in the treatment of subjects diagnosed with acute ischemic stroke. The initiation of the TLT procedure must be feasible for each subject between 4.5 and 24 hours of stroke onset.

Conditions Studied

Interventions

  • DEVICE NeuroThera® Laser System

Study Locations (20)

California

  • Scripps Encinitas Hospital - Encinitas
  • Hoag Memorial Hospital Presbyterian - Newport Beach
  • Stanford Stroke Center - Palo Alto

North Carolina

  • Mission Hospital/Mission Neurology Services - Asheville
  • University of North Carolina Healthcare - Chapel Hill
  • Guilford Neuro/The Moses H. Cone Memorial Hospital - Greensboro

Georgia

  • Gwinnett Medical Center - Duluth
  • Gwinnett Medical Center - Lawrenceville

Massachusetts

  • Massachusetts General Hospital - Boston
  • UMass Memorial Medical Center - Worcester

Missouri

  • Saint Lukes Hospital - Kansas City
  • University of Washington St. Louis - St Louis

Alabama

  • University of Alabama Birmingham - Birmingham

Arkansas

  • Sparks Regional Medical Center - Fort Smith

Florida

  • Munroe Regional Medical Center - Ocala

Trial Details

FieldValue
Enrollment Target 1,000 participants
Start Date 2010-09
Phase Phase 3

Sponsor

PhotoThera

2 total trials

What the Registry Record Tells You About NCT01120301

The ClinicalTrials.gov registry entry for NCT01120301 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 312-participant average among 25 other Acute Ischemic Stroke trials with a reported enrollment target (221% higher). The listed sponsor is PhotoThera, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Acute Ischemic Stroke appearing as the primary indexed condition, and to 1 intervention - of which NeuroThera® Laser System is the first listed.

NCT01120301 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, North Carolina, Georgia.

Frequently Asked Questions

What is clinical trial NCT01120301 about?

NCT01120301 is a clinical study titled "Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3)". The purpose of this pivotal study is to demonstrate safety and efficacy of transcranial laser therapy (TLT) with the NeuroThera® Laser System in the treatment of subjects diagnosed with acute ischemic stroke. The initiation of the TLT procedure must be feasible for each subject between 4.5 and 24 ho...

What is the current status of trial NCT01120301?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,000 participants. The study started on 2010-09.

What conditions does trial NCT01120301 study?

This clinical trial studies the following conditions: Acute Ischemic Stroke.

What interventions are being tested in trial NCT01120301?

The interventions under investigation include: NeuroThera® Laser System (DEVICE).

Who is sponsoring clinical trial NCT01120301?

This trial is sponsored by PhotoThera, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01120301 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.