Ignite Creation Date:
2024-07-17 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488248
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-18
Brief Title:
Endoscopic Third Ventriculostomy vs Ventriculoperitoneal Shunt in Idiopathic Normal Pressure Hydrocephalus ENDOVEST
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Endoscopic Third Ventriculostomy Compared to Ventriculoperitoneal Shunt as Treatment for Idiopathic Normal Pressure Hydrocephalus ENDOVEST A Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this single-center two-arm open-labeled randomized controlled clinical study is to compare two surgical interventions endoscopic third ventriculostomy and ventriculoperitoneal shunt in treating idiopathic normal pressure hydrocephalus in terms of clinical improvement
Detailed Description:
Idiopathic normal pressure hydrocephalus iNPH primarily affects elderly individuals with prevalence rates of approximately 14 among those over 65 years and 59 among those over 80 years old It is characterized by fluid buildup in the brain with normal cerebrospinal fluid pressure and is unique among neurodegenerative disorders in its potential for successful treatment Common symptoms include difficulty walking urinary incontinence and cognitive decline which significantly impact quality of life
The standard treatment involves inserting a ventriculoperitoneal shunt VPS to drain cerebrospinal fluid achieving a 75 success rate in improving symptoms However VPS has a drawback a high rate of revision surgery approximately 18 during follow-up An alternative treatment is endoscopic third ventriculostomy ETV which avoids placing foreign materials and thus eliminates risks associated with shunt malfunction and infections ETV is an established neuroendoscopic procedure mainly used to treat non-communicating hydrocephalus typically due to aqueduct stenosis
This study aims to compare ETV and VPS in treating iNPH to determine their effectiveness in improving clinical outcomes providing future patients with the most effective surgical treatment and a lower risk of complications
The standard treatment involves inserting a ventriculoperitoneal shunt VPS to drain cerebrospinal fluid achieving a 75 success rate in improving symptoms However VPS has a drawback a high rate of revision surgery approximately 18 during follow-up An alternative treatment is endoscopic third ventriculostomy ETV which avoids placing foreign materials and thus eliminates risks associated with shunt malfunction and infections ETV is an established neuroendoscopic procedure mainly used to treat non-communicating hydrocephalus typically due to aqueduct stenosis
This study aims to compare ETV and VPS in treating iNPH to determine their effectiveness in improving clinical outcomes providing future patients with the most effective surgical treatment and a lower risk of complications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None