Study Stopped
The decision to terminate was taken based on study team capacity not sufficient and alignment with the sponsor.
IMPACT of AspireSR® for VNS Therapy on Healthcare Resource Utilisation and Clinical Outcomes.
IMPACT
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.
1 other identifier
observational
15
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2022
CompletedFirst Submitted
Initial submission to the registry
July 3, 2023
CompletedFirst Posted
Study publicly available on registry
August 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2024
CompletedDecember 3, 2024
November 1, 2024
2 years
July 3, 2023
November 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Descriptive comparison of healthcare resource use (HCRU)
Descriptive comparison of secondary HCRU in the 24 month periods before and after AspireSR® device implantation
24 months before and after device implantation
Study Arms (2)
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®.
Eligibility Criteria
Male and female adult (aged ≥18 years at AspireSR® implantation) subjects with epilepsy who have had the VNS device AspireSR® implanted at least 24 months prior to study retrospective data collection.
You may qualify if:
- 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.
You may not qualify if:
- Living subjects for whom consent for researcher access to medical records and extraction of data from HES has not been obtained.
- Deceased subjects.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LivaNovalead
- OPEN VIE Limitedcollaborator
Study Sites (1)
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Wysota
The Queen Elizabeth Hospital
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2023
First Posted
August 4, 2023
Study Start
January 20, 2022
Primary Completion
January 30, 2024
Study Completion
January 30, 2024
Last Updated
December 3, 2024
Record last verified: 2024-11