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

CSF-Dynamics A/S0 个研究点目标入组 15 人开始时间: 2022年11月30日最近更新: 2023年6月20日

适应症

试验速览

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

•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

•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

发起方