Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

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

NCT01120301 · View on ClinicalTrials.gov ↗

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

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01120301

The ClinicalTrials.gov registry entry for NCT01120301 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PhotoThera, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01120301 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, North Carolina, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01120301?

The interventions under investigation include: NeuroThera® Laser System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01120301?

This trial is sponsored by PhotoThera, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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