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Efficacy evaluation of Overflow leak test by 30 mL intrathecal injection

Efficacy evaluation of leak site diagnosis method for cerebrospinal fluid hypovolemia by intrathecal injection of 30 mL of ARTCEREB irrigation and perfusion solution for cerebrospinal surgery : Overflow leak test - EOTA study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061220082
Enrollment
25
Registered
2023-01-12
Start date
2024-01-04
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

cerebrospinal fluid hypovolemia cerebrospinal fluid hypovolemia

Interventions

Overflow leak test Lumbar puncture is performed by the general lumbar puncture method, and 30 mL of ARTCEREB is intramedullarily injected. MRI will be taken within 1 hour after intrathecal injection.
Lumbar puncture

Sponsors

Nakai Eiichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with low cerebrospinal fluid pressure (patients whose cerebrospinal fluid pressure of 60 mmH2O or less has been confirmed even once) 2. Patients over 18 years old 3. Persons who have obtained written consent from the person concerned (in the case of minors and persons who lack consent ability)

Exclusion criteria

Exclusion criteria: 1. Patients who tend to bleed 2. Patients who have difficulty with lumbar puncture 3. Pregnant woman 4. Patients recognized by doctors as ineligible

Design outcomes

Primary

MeasureTime frame
Comparison of the rate at which the leak site could be identified by CT myelography images and the rate at which the leak site could be identified by the 30 mL intrathecal injection Overflow leak test

Secondary

MeasureTime frame
(1) Comparison of the rate at which the leak site could be identified by CT myelography images and the rate at which the leak site could be identified by the Overflow leak test (including discontinued cases) (2) Changes in MRI images before and after the Overflow leak test

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