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Safety of Using NaviFUS System in Patients With Drug Resistant Epilepsy

NCT03860298 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-11-13

No results posted yet for this study

Summary

This study is to evaluate the safety and the intracranial electroencephalography (iEEG) changes of using NaviFUS System for the treatment of patients with drug resistant epilepsy.

Conditions

  • Drug Resistant Epilepsy
  • Epilepsy, Drug Resistant
  • Drug Refractory Epilepsy
  • Epilepsy, Drug Refractory
  • Intractable Epilepsy
  • Epilepsy, Intractable
  • Medication Resistant Epilepsy
  • Refractory Epilepsy

Interventions

DEVICE

NaviFUS System

Using NaviFUS System treatment for 10 minutes in drug resistant epilepsy. The site of the NaviFUS exposure is where the future surgery will be removed. Patients will concomitant use of anti-epileptic drugs (AEDs).

Sponsors & Collaborators

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • NaviFUS Corporation

    lead INDUSTRY

Principal Investigators

  • Hsiang-Yu Yu, M.D. · Taipei Veterans General Hospital, Taiwan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-17
Primary Completion
2020-10-14
Completion
2020-10-14

Countries

  • Taiwan

Study Locations

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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 NCT03860298 on ClinicalTrials.gov