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Evaluation of Overflow leak test

Evaluation of effectiveness of intraspinal injection of cleaning perfusate for cerebrospinal surgery on the diagnosis of cerebrospinal fluid(CSF)-leakage in intracranial hypotension - EICI study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061190002
Enrollment
18
Registered
2019-05-20
Start date
2019-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intracranial hypotension intracranial hypotension

Interventions

20 mL of ARTCEREB Irrigation and Perfusion Solution for Cerebrospinal Surgery will be injected into the subarachnoid space using regular lumbar puncture procedure as an overflow leak test. Injection i
Artcereb injection

Sponsors

Nakai Eiichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patient with intracranial hypotension(Patient confirmed to have cerebrospinal fluid pressure below 60mmH2O) 2. Patient 18 years old or above 3. Written consent concerning participation in this research has been obtained from the participant (or from the individual legal guardian if incapable of consenting)

Exclusion criteria

Exclusion criteria: 1. Patient with a bleeding tendency 2. Patient for whom a lumbar puncture would be difficult 3. Pregnant woman 4. Patient deemed unfit by a doctor

Design outcomes

Primary

MeasureTime frame
Evaluation of the effectiveness of identifying leakage sites with the overflow leak test through comparison of the overflow leak test and CT myelogram

Secondary

MeasureTime frame
(1) Comparison of MRI image findings taken as routine care before Overflow leak test and MRI image findings at Overflow leak test. (2) Name of adverse event, date of onset, severity (severity), severity, treatment for study subject, outcome and date of outcome, causal relationship with the concerned study.

Contacts

Public ContactEiichi Nakai

Kochi Medical School Hospital

enakai@kochi-u.ac.jp+81-88-880-2397

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026