Status:
ACTIVE_NOT_RECRUITING
Non-interventional Study Describing Healthcare Resource Utilisation and Clinical Outcomes Associated With VNS Therapy in UK.
Lead Sponsor:
LivaNova
Collaborating Sponsors:
OPEN VIE Limited
Conditions:
Epilepsy
Eligibility:
All Genders
1+ years
Brief 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 prospect...
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 ...
Eligibility Criteria
Inclusion
- Living subjects who meet all of the following criteria will be considered for enrolment:
- Clinical diagnosis of drug resistant epilepsy
- Subjects who have had their first VNS device (Demipulse®/Aspire HC®, Aspire SR® and SenTiva®) implanted at least 18 months prior to their enrolment in the study data (with no change in generator, battery or lead).
- For SenTiva® and Aspire SR®, AutoStim was first activated within 1 month of implantation.
- For SenTiva®, scheduled dosing mode was activated within 1 month of implantation.
- Subjects must be able and willing to provide informed consent; subjects aged 7-12 years old and 13-15 years old will be provided with appropriate information and consent forms to explain the study in age appropriate language. These subjects will be asked to provide their assent to take part in the study, with consent provided by their parent/carer. Subjects under 7 years will be included in the study with consent from their parent/carer. For adult subjects (≥16 years) lacking the mental capacity to consent, advice about participation will be sought from an appropriate consultee, according to the Mental Capacity Act 2005.
- Adult and paediatric subjects (aged over 2.5 years at study enrolment) with available medical records for at least 12 months prior to VNS device implantation.
Exclusion
- Subjects whose medical records are not available for review.
- Deceased subjects.
Key Trial Info
Start Date :
May 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT04779814
Start Date
May 11 2021
End Date
December 1 2025
Last Update
March 7 2025
Active Locations (5)
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1
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
2
Bristol Royal Hospital For Children
Bristol, United Kingdom
3
The Walton Centre
Liverpool, United Kingdom
4
Nottingham Children's Hospital
Nottingham, United Kingdom