A Safety Evaluation of the Use of Magnetic-guided Iron Particles

NCT01519076 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2014-12-10

No results posted yet for this study

Summary

This study is a prospective trial wherein each included subject will receive the experimental magnetically enhanced diffusion therapy. It will be conducted on a maximum of ten adult male or female patients who meet the inclusion and exclusion criteria and informed consent has been obtained. Subjects presenting in the emergency department with acute ischemic stroke and are eligible for tPA therapy may be considered for inclusion in the study.

Conditions

Interventions

DEVICE

Pulse Therapeutics (PTI) Magnetically-Enhanced Diffusion (MED)

The PTI MED System is a magnetic-controlled infusion system which uses external energy (magnetic energy) to drive an agent (tPA) to the desired target (blood clot).

Sponsors & Collaborators

  • Pulse Therapeutics

    lead INDUSTRY

Principal Investigators

  • Christopher Bladin, MD · Eastern Health Services Box Hill Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-01-31
Completion
2014-07-31

Countries

  • Australia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01519076 on ClinicalTrials.gov