NCT05993117

Rechargeable Implantable Vagus Nerve Stimulation System for Drug-Refractory Epilepsy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Beijing Pins Medical Co., Ltd · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the performance of automatic stimulation mode of a new rechargeable implantable vagus nerve stimulation system for drug-refractory epilepsy

Detailed description

The study is a prospective, single-group, open-lable trial designed to collect data on patients implanted with a Model G114R VNS system (Beijing PINS Medical) from baseline through an EMU (epilepsy monitoring unit) stay of up to 5 days, and 3-mouth follow-up. The seizure burden and quality of life were evaluated. Adverse events were recorded during the trial.

Conditions

• Drug-Refractory Epilepsy

Interventions

Type	Name	Description
DEVICE	G114R VNS system	All patients treated with Rechargeable Implantable Vagus Nerve Stimulation System (G114R)

Timeline

• Start date: 2021-09-01
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2023-08-15
• Last updated: 2023-09-13

Locations

1 site across 1 country: China