NCT06488248 Endoscopic Third Ventriculostomy vs. Ventriculoperitoneal Shunt in Idiopathic Normal Pressure Hydrocephalus (ENDOVEST)
| NCT ID | NCT06488248 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Idiopathic Normal Pressure Hydrocephalus (INPH) |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-01-17 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-01-17 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * \>40 years of age * Symptom duration ≥3 months, \<24 months * No antecedent head trauma, ICH, meningitis, or other cause of secondary hydrocephalus * MUST show gait/balance disturbance, PLUS cognition impairment AND/OR urinary dysfunction. * Ventricular enlargement (Evans Index \> 0.3) not attributable to cerebral atrophy or congenital enlargement * No macroscopic obstruction to cerebrospinal fluid (CSF) flow Spinal Tap-Test * Opening pressure (on lateral decubitus): \<24cmH2O * Clinical improvement in at least one of the main symptoms after 40-50ml withdrawal of CSF Exclusion Criteria: * ≤40 years of age * No informed consent * Other neurologic, psychiatric or general medical condition which is sufficient to explain the presenting symptoms. * Previous cranial neurosurgical interventions * Other associated dementia syndromes * Incapacity to walk * Pregnancy and breastfeeding women
Contact & Investigator
Florian Marc Ebel, Dr. med.
PRINCIPAL INVESTIGATOR
Department of Neurosurgery, University Hospital of Basel
Frequently Asked Questions
Who can join the NCT06488248 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Idiopathic Normal Pressure Hydrocephalus (INPH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06488248 currently recruiting?
Yes, NCT06488248 is actively recruiting participants. Contact the research team at florianmarc.ebel@usb.ch for enrollment information.
Where is the NCT06488248 trial being conducted?
This trial is being conducted at Basel, Switzerland.
Who is sponsoring the NCT06488248 clinical trial?
NCT06488248 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Florian Marc Ebel, Dr. med. at Department of Neurosurgery, University Hospital of Basel. The trial plans to enroll 150 participants.