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

Not Applicable

Completed

• Conditions: Hydrocephalus; Nervous System Diseases

• Registration Number: ISRCTN17896279
• Lead Sponsor: CSF-Dynamics A/S

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37086160/ (added 06/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-09-20
• Study Start: 2022-11-30
• Last Update Posted: 20 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified