Testing a drainage device for the treatment of hydrocephalus (a build-up of fluid in the brain)
| ISRCTN | ISRCTN17896279 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17896279 |
- Submission date
- 29/11/2022
- Registration date
- 30/11/2022
- Last edited
- 06/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
In a healthy individual, 400-500ml of brain fluid (also known as cerebrospinal fluid or CSF) is produced daily and passes around the brain before being re-absorbed into the bloodstream. Hydrocephalus (or “fluid on the brain”) is the condition where the flow of CSF becomes blocked, resulting in increased pressure within the brain cavity which can cause brain damage and eventually death if not treated.
There is no cure for the cause of hydrocephalus, but the condition is usually treated by having a shunt implanted which diverts the fluid from the ventricles of the brain to another part of the body (most often the stomach) where it re-enters the bloodstream. Hydrocephalus shunts save lives but the five-year survival rate for hydrocephalus shunts is only about fifty per cent. In fact, thirty per cent of patients are re-operated within three months due to shunt failure. This high failure rate is only accepted because there is no alternative treatment option. Since hydrocephalus patients are shunt dependent for life, patients, patient associations and surgeons are all desperate for better and more durable solutions.
CSF-Dynamics A/S has developed a new type of shunt, the SinuShunt®. The principle behind this shunt is that it mimics the normal physiological outflow of cerebrospinal fluid, directing the fluid into the vein in the head which is where CSF would normally drain. The design of the drain outlet (known as the VAP or Venous Access Port) is shaped like a stent. Stents are commonly used to keep blood vessels open, however in this case the stent is used to support the outlet in the centre of the vein. This part of the design is critical in preventing the outlet from drifting to the side of the vein where it could settle into the wall of the vein and become blocked.
The purpose of the study is to test the new outlet and ensure that it functions continuously for a period of 6 months.
Who can participate?
Only participants over the age of 18 who are suffering from hydrocephalus, need a hydrocephalus shunt and who fulfil all inclusion criteria will be admitted to the study.
What does the study involve?
Participants will be operated in the same way as standard hydrocephalus shunts with the exception that the shunt outlet will be run to the jugular vein in the neck rather than the stomach. All patients will be operated in the same way and will be followed up at three and six months where the shunt system will be checked to ensure there is through-flow.
What are the possible benefits and risks of participating?
The benefit of participating in this study is that the device is designed to lengthen the average lifespan of the shunt system. The average lifespan of a standard shunt which diverts brain fluid to the stomach is 75% at six months. The VAP is designed to overcome issues of modern-day shunts and never need replacing.
There are two significant risks, the risk of blood clots and the risk of nerve irritation.
The VAP will be positioned on the right-hand side of the head. There is a possibility that locating the VAP in the middle of the vein may cause blood clots around the end of the outlet, and that this may block the flow of blood. To ensure that this risk does not become life-threatening if it happens, all patients will be checked to ensure they have continuous double outflow of blood, so that blood can still flow on the right side of the head should a blockage occur. In addition, to prevent any possible blood clot formation, the participant will be treated with 75mg of aspirin per day for the first 8 weeks after surgery. If a blood clot does form, the VAP will be removed and replaced by a standard shunt.
There is a also risk of nerve irritation because some nerves also pass through the hole in the base of the skull where the VAP will be positioned. These nerves are separated from the vein by a fibrous membrane which might be affected by the springy nature of the VAP, although this is unlikely due to the size and force of the device. This irritation has symptoms of spinning sensations behind the ear, dryness in the mouth and reduced sense of touch at the back of the tongue. These symptoms will be checked at the three and six month follow ups. If the discomfort is persistent, the VAP will be removed and replaced by a standard shunt.
Where is the study run from?
Odense University Hospital, Denmark
When is the study starting and how long is it expected to run for?
February 2019 to September 2022
Who is funding the study?
CSF-Dynamics A/S (Denmark)
European Innovation Council
Who is the main contact?
Dr Sune Munthe, sune.munthe@rsyd.dk
Contact information
Principal Investigator
Neurokirurgisk Afdeling U
Sdr. Boulevard 29
Odense C
5000
Denmark
 ORCID ID |
0000-0002-4793-9803 |
|---|---|
| Phone | +45 24 99 63 88 |
| sune.munthe@rsyd.dk |
Study information
| Study design | Single-arm single-centre prospective interventional feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Test of Venous Access Port: feasibility study of a drainage device for the treatment of hydrocephalus |
| Study objectives | Shunt survival at 6 months will be 10% better than the average standard shunt lifespan at 6 months of 75%. |
| Ethics approval(s) | Approved 22/02/2020, Ethics Committee of the Capital Region (Kongens Vænge 2, 3400 Hillerød, Denmark; +45 38 66 63 95; vek-anmeldelse.center-for-sundhed@regionh.dk), ref: H-19083791 |
| Health condition(s) or problem(s) studied | Hydrocephalus |
| Intervention | 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 subcutaneous one-way valve, a subcutaneous silicone tube and a shunt-outlet placed intravascularly at the top of the internal jugular vein in the jugular foramen. The shunt outlet is the investigational device and is also known as the Venous Access Port (VAP). Shunt survival and function is tested by a water-column test through puncturing of control-reservoir and measuring pressure by height of water column and observing free inflow/no flow) at 3 months and 6 months. Medication: antiplatelet treatment post-operatively with 75 mg aspirin per day for 8 weeks. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Venous Access Port (VAP) |
| Primary outcome measure | VAP remains open at the 3 month and 6 month endpoint tested by water column test |
| Secondary outcome measures | 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. |
| Overall study start date | 01/02/2019 |
| Completion date | 20/09/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 15 |
| Total final enrolment | 15 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 22/06/2020 |
| Date of final enrolment | 25/02/2022 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Sdr. Boulevard 29
Odense C
5000
Denmark
Sponsor information
Industry
Gl. Lundtoftevej 1D
Lyngby
DK – 2800
Denmark
| Phone | +45 93869371 |
|---|---|
| kg@csf-dynamics.com | |
| Website | https://www.csf-dynamics.com/ |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- EU Framework Programme for Research and Innovation, Horizon 2020 - Research and Innovation Framework Programme, European Union Framework Programme for Research and Innovation
Results and Publications
| Intention to publish date | 01/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in high impact peer-reviewed journal |
| IPD sharing plan | Published as a supplement to the results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 21/04/2023 | 06/06/2023 | Yes | No |
Editorial Notes
06/06/2023: Publication reference added.
17/03/2023: The total final enrolment number was changed from 16 to 15. The intention to publish date was changed from 01/03/2023 to 01/06/2023.
30/11/2022: Trial's existence confirmed by Ethics Committee of the Capital Region.
