Testing a drainage device for the treatment of hydrocephalus (a build-up of fluid in the brain)

Test of Venous Access Port: feasibility study of a drainage device for the treatment of hydrocephalus

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17896279

Enrollment

Registered

2022-11-30

Start date

2020-06-22

Completion date

Unknown

Last updated

2023-06-20

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

Conditions

Hydrocephalus Nervous System Diseases

Interventions

Implantation of Venous Access Port (VAP) as part of a shunt system for treatment of hydrocephalus. Shunt comprises a cerebral ventricular catheter, a subcutaneous control-reservoir, a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Neuroradiologically verified enlarged ventricular system 2. Either one or more of the following symptoms of hydrocephalus requiring treatment: headache, nausea, visual disturbances, cognitive dysfunction, difficulty walking, urinary incontinence, or have a previously implanted shunt that requires revision 3. Reserve drainage (cross-flow) to opposite sinuses transversus, demonstrated by MRI venogram 4. Jugular foramen with minimum diameter >7 mm on MRI scan 5. Normal lung scintigraphy with no evidence of sequelae from previous blood clots in the lungs 6. Normal coagulation status 7. May be treated by one of the surgeons associated with the study. 8. Is 18 years of age or older 9. Provision of signed informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnant (test: urine stick HCG test, laboratory test code NPU10394) 2. Normal size ventricular system 3. Suspected of having multiple infarctus or leukodystrophic changes that may cause enlarged ventricular system 4. Paraclinical signs of affected coagulation function 5. Known allergy to nickel, Zinacef™ or acetylsalicylic acid

Design outcomes

Primary

Measure	Time frame
VAP remains open at the 3 month and 6 month endpoint tested by water column test	—

Secondary

Measure	Time frame
1. Registration of clinical symptoms at inclusion and at 3 and 6 month follow-up measured using: 1.1. gait disturbances, evaluated by investigator in three levels (normal gait, moderate disturbance, severe disturbance) 1.2. dementia degree, evaluated by investigator in three levels (no dementia, moderate dementia, severe dementia) 1.3. incontinence evaluated by investigator in three levels (no incontinence, moderate incontinence, severe incontinence) 2. Overdrainage measured using MRI scan at 3 and 6 month follow up: observation of subdural haematoma or CSF effusion. Measurement of Evans' ratio.	—

Measure

Time frame

1. Registration of clinical symptoms at inclusion and at 3 and 6 month follow-up measured using: 1.1. gait disturbances, evaluated by investigator in three levels (normal gait, moderate disturbance, severe disturbance) 1.2. dementia degree, evaluated by investigator in three levels (no dementia, moderate dementia, severe dementia) 1.3. incontinence evaluated by investigator in three levels (no incontinence, moderate incontinence, severe incontinence) 2. Overdrainage measured using MRI scan at 3 and 6 month follow up: observation of subdural haematoma or CSF effusion. Measurement of Evans' ratio.

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Countries

Denmark

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026