NCT04779814Leállítva
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.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. márc. 25.
Megadott ok: The study was terminated by the sponsor due to persistent delays in recruitment and data availability, including access to the healthcare resource utilization database, which made it difficult to generate meaningful outcomes.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Leállítva
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 97 (tényleges)
- Első benyújtás
- 2021. febr. 24.
- Kezdés
- 2021. máj. 11.
- Elsődleges befejezés
- 2025. aug. 19.
- Fő szponzor
- LivaNova
- Betegségek
- Epilepszia
- NCT-szám
- NCT04779814
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Egyéb
- Subjects whose medical records are not available for review.
- Deceased subjects.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 1 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (5)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Queen Elizabeth Hospital Birmingham | Birmingham | Egyesült Királyság | Ismeretlen állapot |
| Bristol Royal Hospital for Children | Bristol | Egyesült Királyság | Ismeretlen állapot |
| The Walton Centre | Liverpool | Egyesült Királyság | Ismeretlen állapot |
| Nottingham Children's Hospital | Nottingham | Egyesült Királyság | Ismeretlen állapot |
| Oxford University Hospital NHSFT | Oxford | Egyesült Királyság | Ismeretlen állapot |
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