NCT06488248|Recruiting
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Sponsor study identifier
interventional
150
1 country
1
Study Start
January 17, 2025
Actual (reported)Primary Completion
July 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 18, 2024
Actual (reported)July 5, 2024
Actual (reported)January 17, 2025
Actual (reported)July 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
idiopathic normal pressure hydrocephalus (iNPH) score
The idiopathic normal pressure hydrocephalus (iNPH) score is used to measure the clinical improvement and complication rate. The iNPH score evaluates the three cardinal symptoms of iNPH-gait disturbance, dementia, and urinary incontinence-with each category assigned a score between 0 and 4 based on severity, resulting in a total score ranging from 0 (indicating normal) to 12 (reflecting the maximum severity of symptoms The score will be assessed during the outpatient consultation before surgery, at admission directly preceding surgery, and postoperatively at discharge, as well as during follow-up at 6-8 weeks, 6 months, and 12 months after the operation.
Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery
Level of consciousness (Glasgow Coma Scale)
Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery
Degree of disability and dependency (modified Rankin Scale)
Up to 5 days, 2, 6, and 12 months after surgery
Cognitive function (Montreal Cognitive Assessment)
Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery
GaitRite walkway
At 2 and 12 months after surgery
Timed-Up-and-Go Test
At 2 and 12 months after surgery
The investigational group undergoes endoscopic third ventriculostomy (ETV) for the treatment of idiopathic normal pressure hydrocephalus (iNPH).
The control group undergoes ventriculoperitoneal shunt (VPS) implantation for the treatment of iNPH.
The procedure is performed using an endoscope (LOTTA® system, Karl Storz Endoscopes, Germany; Minop®, BBraun, Tuttlingen, Germany or equivalent). The intervention is carried out under general anesthesia, with the procedure typically lasting around 60 minutes.
The procedure entails the insertion of a catheter into both the ventricular system and the peritoneal cavity, connected to a programmable valve that regulates cerebrospinal fluid flow. The choice of programmable valve (Codman Hakim or Codman Certas Programmable Valves, Integra, Plainsboro, USA; Strata valve, Medtronic, Minneapolis, USA; Sophysa, Orsay, France; Miethke proGAV, Aesculap, Tuttlingen, Germany) is at the surgeon's discretion. The preoperative valve setting is preset to a pressure level between 85 - 135 mmH2O. The VPS procedure is conducted under general anesthesia and typically lasts approximately 90-120 minutes.
Department of Neurosurgery, University Hospital of Basel
Basel, 4031, Switzerland
Florian Marc Ebel, Dr. med.
Department of Neurosurgery, University Hospital of Basel
First Submitted
June 18, 2024
First Posted
July 5, 2024
Study Start
January 17, 2025
Actual (reported)Primary Completion
July 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Functional Outcomes After LumbOpenitoneal Shunt Placement UndeR Local Anesthesia for Patients With Idiopathic Normal preSsure Hydrocephalus (FLOURISH) Trial
Third Ventriculostomy Versus Shunt for Children With Hydrocephalus
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Study Completion
July 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 3, 2025
Record last verified: 2025-01
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Source: ClinicalTrials.gov.
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