NCT03860298

Safety of Using NaviFUS System in Patients With Drug Resistant Epilepsy

A Phase I, Two-stage, and Open Label Study to Evaluate the Safety and Tolerability of Using NaviFUS System in Patients With Drug Resistant Epilepsy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: NaviFUS Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase I, two-stage, prospective, open label, single center, and single-arm study. Eligible patients will be enrolled through the process of informed consent then will receive NaviFUS treatment one cycle. The time interval for each treatment cycle is 3 days, including baseline/treatment and 3 days observation. The site of the NaviFUS exposure is where the future surgery will be removed. Concomitantly use of anti-epileptic drugs (AEDs) will be monitored and recorded in the case report form (CRF). A total of six patients will be divided into two stages of recruitment, the first stage will recruit two patients, the second stage will be four patients. When the first stage is accomplished, the data and safety monitoring board (DSMB) will review the study data and provide the recommendations regarding continuation, termination, or other modifications of the study based on evaluation of observed adverse effects of the intervention. The second stage will begin to conduct after the DSMB agrees to proceed. In this clinical trial, stereo-electroencephalography (SEEG) exploration will be carried out during long-term video-EEG monitoring and excitability/irritability in focal epileptogenic region and epileptogenic network will be analyzed.

Conditions

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2019-06-17
• Primary completion: 2020-10-14
• Completion: 2020-10-14
• First posted: 2019-03-01
• Last updated: 2020-11-13

Locations

1 site across 1 country: Taiwan