Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629168
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
The Usage of Telemetric Prechamber Sensor Reservoir in Management of Normal Pressure Hydrocephalus Comparisson of Benefit for Patients with Implanted Telemetric Prechamber Sensor Reservoir
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Usage of Telemetric Prechamber Sensor Reservoir in Management of Hydrocephalus
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Normal pressure hydrocephalus NPH is a preventable and treatable cause of dementia However as a nosological entity it is significantly underdiagnosed often being mistakenly classified as presenile or senile dementia without further investigation Ongoing management is crucial currently relying mainly on indirect methods-clinical and imaging-based Telemetry offers a real-time online method to assess actual cerebrospinal fluid pressures which are crucial for patient management Telemetry allows for tailoring treatment to the individual patient This project is planned as a pilot study before a more extensive research project
Detailed Description:
Normal pressure hydrocephalus NPH is a preventable and treatable cause of dementia However as a nosological entity it is significantly underdiagnosed often being mistakenly classified as presenile or senile dementia without further investigation Diagnosing NPH is not straightforward it is based on a series of examinations the results of which determine whether the patient is a responder and therefore a candidate for shunt surgery implantation of a ventriculoperitoneal shunt The medical literature identifies additional criteria that predict whether the implantation of the shunt will have a good or poor effect However treatment from a neurosurgical perspective does not end there Ongoing management is crucial currently relying mainly on indirect methods-clinical and imaging-based Telemetry offers a real-time online method to assess actual cerebrospinal fluid pressures which are crucial for patient management Telemetry allows for tailoring treatment to the individual patient This project is planned as a pilot study before a more extensive research project
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None