TerminatedNo phase
IMPACT of AspireSR® for VNS Therapy on Healthcare Resource Utilisation and Clinical Outcomes.
Key facts
- Who runs it
- LivaNova
- Where
- United Kingdom1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 15 people enrolled
- Started
- 20 Jan 2022
- Ended
- 30 Jan 2024
- Type of study
- Observational, 2 groups
- Record updated
- 3 December 2024
- Why it stopped
- The decision to terminate was taken based on study team capacity not sufficient and alignment with the sponsor.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- Age ≥18 years at AspireSR® device implantation
- VNS device AspireSR® implantation for the first time or battery change from a previous model to AspireSR® at least 24 months prior to the start of retrospective data collection from medical records
- Subjects for whom written informed consent has been provided for researcher access to their medical records and extraction of data from HES (if the subject is living and has capacity to consent) or advice from a consultee (if the subject is living but lacks capacity to consent)
- Subjects with available medical history for at least 24 months prior to Aspire SR® implantation
Who cannot take part
- Living subjects for whom consent for researcher access to medical records and extraction of data from HES has not been obtained
- Deceased subjects
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
This is a retrospective non-interventional study to describe the HCRU and clinical outcomes before and after AspireSR® device implantation in subjects with drug resistant epilepsy at the Queen Elizabeth Hospital, Birmingham (QEHB).
The 2 groups in the trial
- Cohort 1 ("new insertions cohort")
Subjects who have had Aspire SR® implanted as their first VNS model.
- Cohort 2 ("battery change cohort")
Subjects who have had their VNS battery changed from a previous model to Aspire SR®.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Single-centre, Non-interventional, Retrospective Study to Describe the IMPACT of AspireSR® for Vagus Nerve Stimulation (VNS) Therapy on Healthcare Resource Utilisation and Clinical Outcomes.
- Record updated
- 3 December 2024