NCT07447479|WithdrawnPhase 4DMC
Study Stopped
Before the enrolment of participants, the principal investigator was fired, and the study site did not allow the continuation of the study.
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Before the enrolment of participants, the principal investigator was fired, and the study site did not allow the continuation of the study.
FLOURISH
Sponsor study identifier
Secondary identifiers
OTHER · Hyogo Medical University
interventional
0
1 country
1
Study Start
April 1, 2026
Actual (reported)Primary Completion
April 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study is a prospective observational registry study that enrolls all patients aged 60 years or older suspected of having idiopathic normal pressure hydrocephalus based on the Third Edition of the Guidelines for the Diagnosis and Treatment of Idiopathic Normal Pressure Hydrocephalus. From the cohort registered, patients judged to be candidates for surgery based on the 3rd Edition of the Guidelines for the Diagnosis and Treatment of Idiopathic Normal Pressure Hydrocephalus. These patients will be randomized 1:1 to undergo either ventriculoperitoneal shunt surgery under general anesthesia or lumbar peritoneal shunt surgery under local anesthesia. A randomized clinical trial would attest the non-inferiority of lumbar peritoneal shunt surgery under local anesthesia compared to ventriculoperitoneal shunt surgery under general anesthesia regarding the improvement in timed up-and-go test scores at 3 months post-surgery relative to pre-surgery levels.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2031
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.
February 22, 2026
Actual (reported)March 3, 2026
Actual (reported)April 1, 2026
Actual (reported)April 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in timed up and go test score
3 months
Intensive Care Delirium Screening Checklist score
24 hours
10% or greater improvement in the timed up and go score
3 months
Change in timed up and go score
1 month
Change in timed up and go score
6 months
Change in timed up and go score
12 months
All-cause deaths
3 months
All-cause deaths
12 months
Development of chronic subdural hematoma (hematoma thickness ≥10 mm)
3 months
ventriculoperitoneal shunt procedure was performed via right posterior horn puncture under general anesthesia
Pentazocine and midazolam are administered intravenously to induce conscious sedation, and a lumbar-peritoneal shunt procedure is performed using local infiltration anesthesia with 1% lidocaine.
Nadogaya Hospital
Kashiwa, Chiba, 277-0084, Japan
Takeshi Morimoto, MD, PhD, MPH
Hyogo Medical University
0 participants (actual enrollment reported by the registry).
First Submitted
February 22, 2026
First Posted
March 3, 2026
Study Start
April 1, 2026
Actual (reported)A Placebo-Controlled Effectiveness in INPH Shunting (PENS) Trial
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
April 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 21, 2026
Record last verified: 2026-07
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Source: ClinicalTrials.gov.
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