NCT04779814

Non-interventional Study Describing Healthcare Resource Utilisation and Clinical Outcomes Associated With VNS Therapy in UK.

A Non-interventional Study Describing the Healthcare Resource Utilisation and Clinical Outcomes Associated With LivaNova Vagus Nerve Stimulation Therapy in the UK.

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 97 (actual)
• Sponsor: LivaNova · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

This is a UK, multi-center, non-interventional study based on the use of health service administrative and medical records (paper-based and/or electronic, as applicable) along with the use of prospectively collected subject-reported outcomes on experience with use of VNS therapy using validated and bespoke self-completion questionnaires. Data for hospital resource utilisation will be extracted from the Hospital Episode Statistics (HES) database.

Detailed description

Failure to control seizures in subjects with treatment resistant epilepsy can have a significant burden on the healthcare system. Vagus Nerve Stimulation (VNS) is an adjunctive treatment for patients with drug resistant epilepsy and is reported to reduce the frequency of seizures in adults and children. However, real-world data on healthcare resource utilization by patients with treatment-resistant epilepsy and their clinical outcomes prior to and post VNS device implantation in the UK are limited. The current study aims to describe the resource utilization and clinical outcomes prior to and following the implantation of different VNS devices (Demipulse®/Aspire HC®, Aspire SR® and SenTiva®) in subjects with drug resistant epilepsy

Conditions

• Epilepsy

Timeline

• Start date: 2021-05-11
• Primary completion: 2025-08-19
• Completion: 2025-08-19
• First posted: 2021-03-03
• Last updated: 2026-03-25

Locations

5 sites across 1 country: United Kingdom