eShunt Implant for Normal Pressure Hydrocephalus

Recruiting at 10 trial locations

Overseen By Randy Burrington

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: CereVasc Inc

Must not be taking: Heparin, Radiographic contrast agents

Disqualifiers: Obstructive hydrocephalus, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 1 day

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new device called the eShunt System for patients with normal pressure hydrocephalus. The device helps drain extra fluid from the brain to the veins, which can improve symptoms like walking difficulties, memory issues, and bladder control problems.

Do I have to stop taking my current medications for the eShunt trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more information.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the idea that eShunt Implant for Normal Pressure Hydrocephalus is an effective treatment?

The available research does not provide any data on the effectiveness of the eShunt Implant for Normal Pressure Hydrocephalus. All the studies focus on treatments for metastatic hormone-sensitive prostate cancer, which is unrelated to the eShunt Implant. ^{1 2 3 4 5}

What safety data exists for the eShunt Implant for Normal Pressure Hydrocephalus?

The provided research does not specifically mention the eShunt Implant or its variants like the eShunt System or CereVasc eShunt. However, it discusses various shunt systems and valves used in the treatment of normal pressure hydrocephalus (NPH), focusing on complications such as overdrainage and subdural hematomas. Studies highlight the use of programmable and anti-siphon valves to reduce these complications. While these studies provide insights into the safety and efficacy of different shunt systems, they do not directly address the safety data for the eShunt Implant. ^{6 7 8 9 10}

Is the eShunt Implant safe for use in humans?

The available research on shunt systems for normal pressure hydrocephalus suggests that complications like overdrainage and subdural hematomas can occur, but the use of certain valves, such as those with anti-siphon devices, may reduce these risks. While specific safety data for the eShunt Implant is not provided, similar devices have been studied for safety, showing that programmable and anti-siphon valves can lower complication rates. ^{6 7 8 9 10}

Is the eShunt Implant a promising treatment for normal pressure hydrocephalus?

The eShunt Implant is a promising treatment for normal pressure hydrocephalus because it offers a new way to manage the condition by potentially improving the drainage of cerebrospinal fluid, which can help relieve symptoms in patients. ^{11 12 13 14 15}

How is the eShunt Implant treatment different from other treatments for normal pressure hydrocephalus?

The eShunt Implant is unique because it offers a less invasive alternative to traditional shunt systems like the ventriculoperitoneal shunt, potentially reducing complications associated with more invasive surgeries. Unlike other treatments that require programmable valves or additional components, the eShunt System may simplify the management of cerebrospinal fluid in normal pressure hydrocephalus. ^{11 12 13 14 15}

Eligibility Criteria

This trial is for people aged 65-85 with normal pressure hydrocephalus, who have trouble walking and thinking clearly, and sometimes can't control their bladder. They should be able to get an MRI or CT scan that shows they're a good fit for the eShunt implant and have had some improvement after a spinal tap test.

Inclusion Criteria

Pre-procedure MRI confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by subject screening committee (SSC)

I show signs of NPH with issues in walking, thinking, or bladder control and my MRI shows specific brain changes.

My cognitive function score is 12 or higher.

Exclusion Criteria

Currently participating in another investigational drug or device trial that could conflict with study data collection or follow-up

I currently have an infection in my body or in my brain/spinal fluid.

I have not had a stroke or mini-stroke in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the eShunt Implant through a minimally invasive procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

5 visits in the first year, then every 6 months

Treatment Details

Interventions

• eShunt Implant

Trial Overview The study tests the eShunt System, which includes placing a permanent implant in the brain through a minimally invasive procedure. It aims to drain excess fluid into the venous system to ease symptoms like gait disturbances, cognitive issues, and urinary problems.

Participant Groups

Group I: Treatment Arm Experimental Treatment 1 Intervention

The Treatment Arm receives the eShunt Implant.

eShunt Implant is already approved in United States for the following indications:

Approved in United States as eShunt System for:

• Normal Pressure Hydrocephalus

Who Is Running the Clinical Trial?

CereVasc Inc

Lead Sponsor

Trials

5

Recruited

340+

AlvaMed, Inc.

Collaborator

Trials

4

Recruited

110+

AlvaMed, Inc.

Industry Sponsor

Trials

4

Recruited

110+

Simplified Clinical Data Systems, LLC

Industry Sponsor

Trials

7

Recruited

300+

Findings from Research

In a study of 879 patients with metastatic hormone-sensitive prostate cancer, local treatment (like radical prostatectomy or radiation therapy) significantly improved overall survival compared to androgen-deprivation therapy alone, particularly in patients without a history of cerebrovascular disease.

Patients with a history of cerebrovascular disease did not experience the same survival benefits from local treatment, indicating that prior CVD may limit the effectiveness of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Cerebrovascular Disease on Survival Benefits from Local Treatment in Patients with De Novo Metastatic Hormone-Sensitive Prostate Cancer. Kim, TJ., Yu, YD., Park, DS., et al.[2020]

Adding abiraterone acetate plus prednisone/prednisolone (AAP) to androgen deprivation therapy (ADT) significantly reduces the risk of death in men with metastatic hormone-sensitive prostate cancer (mHSPC) by 38%, translating to a 14% absolute improvement in overall survival over three years, based on data from two major trials involving 82% of participants.

The addition of AAP also leads to a 55% reduction in the risk of clinical or radiological progression-free survival, with a 28% absolute improvement at three years, although there is an increased risk of certain grade III-IV toxicities, particularly cardiac and hepatic, without an increase in overall mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding abiraterone to androgen deprivation therapy in men with metastatic hormone-sensitive prostate cancer: A systematic review and meta-analysis. Rydzewska, LHM., Burdett, S., Vale, CL., et al.[2023]

Triplet therapy for metastatic hormone-sensitive prostate cancer (mHSPC) showed the best overall survival (OS) and radiographic progression-free survival (rPFS) outcomes compared to other treatments, with a hazard ratio of 0.57 for OS and 0.33 for rPFS based on a network meta-analysis of 12 trials involving 18 publications.

While triplet therapy was the most effective, it also carried a higher risk of adverse events (AEs) compared to other therapies, with docetaxel-based treatments significantly increasing the risk of severe AEs. In contrast, ADT plus rezvilutamide had a lower incidence of AEs, making it a safer option among doublet therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination therapy for high-volume versus low-volume metastatic hormone-sensitive prostate cancer: A systematic review and network meta-analysis. Jian, T., Zhan, Y., Yu, Y., et al.[2023]

Recent studies show that combining androgen deprivation therapy (ADT) with docetaxel or second-generation androgen-receptor pathway inhibitors (ARPIs) significantly improves survival outcomes for patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to ADT alone.

The ARASENS trial indicates that triplet therapy (ADT plus docetaxel and an ARPI) benefits various subpopulations of mHSPC patients, particularly those with high-volume disease, while ongoing trials are exploring the role of radiotherapy in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Treatment Intensification in Metastatic Hormone-Sensitive Prostate Cancer. Wala, J., Nguyen, P., Pomerantz, M.[2023]

Combination therapies, including docetaxel chemotherapy and new androgen receptor-targeted agents like abiraterone and enzalutamide, have shown to be more effective than traditional androgen deprivation therapy alone for treating metastatic hormone-sensitive prostate cancer (mHSPC).

The study aims to create a predictive model to assess the risk of symptomatic progression, new treatment initiation, and mortality in mHSPC patients based on their characteristics at admission, reflecting the evolving understanding of this complex disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research protocol to identify progression and death amongst patients with metastatic hormone-sensitive prostate cancer treated with available treatments: PIONEER IMI's "big data for better outcomes" program. Gomez Rivas, J., Nicoletti, R., Ibáñez, L., et al.[2023]

The SVASONA trial aims to determine if a new shunt assistant valve (proGAV) can reduce the incidence of overdrainage in patients with idiopathic normal-pressure hydrocephalus (iNPH) from 25% to 10%, compared to a conventional programmable valve.

This pragmatic randomized controlled trial will involve 200 patients and assess not only the rate of overdrainage but also patient-centered outcomes, including quality of life and complications, with interim analyses planned for safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is it possible to minimize overdrainage complications with gravitational units in patients with idiopathic normal pressure hydrocephalus? Protocol of the randomized controlled SVASONA Trial (ISRCTN51046698). Lemcke, J., Meier, U., Müller, C., et al.[2019]

In a study of 117 patients with normal pressure hydrocephalus, the Miethke Dual Switch Valve (DSV) showed significantly fewer complications related to overdrainage and subdural hematomas compared to the Cordis Orbis Sigma Valve Type I (OSV), which had a higher incidence of these issues.

The study suggests that the choice of valve type can influence the clinical outcomes in patients with normal pressure hydrocephalus, with the DSV being a safer option for minimizing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical experience with various shunt systems in normal pressure hydrocephalus]. Meier, U., Zeilinger, FS., Reyer, T., et al.[2019]

In a study of 35 adult patients with hydrocephalus and risk factors for overdrainage, the use of fixed-pressure valves with an antisiphon device (SPHERA®) resulted in a sustained clinical improvement in 94.3% of patients over a two-year period.

There were no significant complications or CT evidence of hypo or overdrainage, indicating that this intervention is both safe and effective for managing hydrocephalus in at-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of fixed-pressure valve with antisiphon device SPHERA(®) in hydrocephalus treatment and overdrainage prevention. Pinto, FC., Pereira, RM., Saad, F., et al.[2019]

In a study of 30 patients with normal pressure hydrocephalus (NPH), those treated with the SPHERA® valve, which includes an anti-siphon device, experienced similar clinical improvements compared to those treated with the PS Medical® valve.

The SPHERA® valve group had significantly fewer complications related to overdrainage, indicating it may be a safer option for managing NPH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of the fixed pressure valve with antisiphon device SPHERA® in the treatment of normal pressure hydrocephalus and prevention of overdrainage. Pereira, RM., Suguimoto, MT., Oliveira, MF., et al.[2019]

Over 75% of patients with idiopathic normal pressure hydrocephalus showed improvement in symptoms after various CSF diversion procedures, with no significant differences in outcomes among the different techniques used.

Using programmable valves in shunting procedures led to fewer revision surgeries (12% vs 32%) and lower rates of subdural fluid collections (9% vs 22%) compared to fixed valves, suggesting they may be a more effective option despite their higher initial cost.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and complications of different surgical treatments for idiopathic normal pressure hydrocephalus: a systematic review and meta-analysis. Giordan, E., Palandri, G., Lanzino, G., et al.[2019]

In a study of 19 elderly patients with idiopathic normal-pressure hydrocephalus (NPH) who underwent shunt revision, 58% experienced significant improvements in walking speed after switching to an adjustable gravitational valve system.

The findings suggest that patients who relapse after initial VP shunting may benefit from further CSF drainage using adjustable valves, which can effectively manage symptoms even at ultra-low CSF pressures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-low-pressure hydrocephalic state in NPH: benefits of therapeutic siphoning with adjustable antigravity valves. Funnell, JP., D'Antona, L., Craven, CL., et al.[2021]

In a study of 42 patients with idiopathic normal pressure hydrocephalus (INPH), those treated with ventriculoperitoneal shunt (VPS) showed significantly better functional neurological outcomes after 12 months compared to those treated with endoscopic third ventriculostomy (ETV).

The VPS group had a 76.9% improvement in neurological function, while the ETV group only had a 50% improvement, indicating that VPS may be the more effective treatment option for INPH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of endoscopic third ventriculostomy and ventriculoperitoneal shunt in idiopathic normal pressure hydrocephalus: preliminary results of a randomized clinical trial. Pinto, FC., Saad, F., Oliveira, MF., et al.[2022]

In a case study of a patient with normal pressure hydrocephalus (NPH), a programmable valve was implanted, but a lower opening pressure led to the development of a subdural hematoma despite symptom relief.

After evacuating the hematoma and increasing the valve pressure, the patient fully recovered, indicating that a higher pressure setting was necessary for optimal management of NPH symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the appropriate shunt system for normal pressure hydrocephalus? Chrissicopoulos, C., Mourgela, S., Kirgiannis, K., et al.[2016]

In a study involving 10 patients with normotensive hydrocephalus, implantation of a ventriculo-atrial valve showed promising results over a follow-up period of 1 to 5 years.

The study highlights the importance of Fisher's test for cerebrospinal fluid removal as a valuable tool in determining eligibility for this surgical treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical aspects and diagnostic difficulties in normotensive hydrocephalus]. Pryszmont, M., Lebkowski, J., Szwaykowski, W.[2015]

In a study involving 344 children with hydrocephalus, it was found that 40% of standard cerebrospinal fluid shunts fail within the first year, primarily due to shunt obstruction and infection.

The two new shunt valve designs, aimed at reducing excess flow, did not significantly improve shunt failure rates compared to standard differential-pressure valves, with similar failure-free durations observed across all valve types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of cerebrospinal fluid shunt valve design in pediatric hydrocephalus. Drake, JM., Kestle, JR., Milner, R., et al.[2022]

References

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Impact of Cerebrovascular Disease on Survival Benefits from Local Treatment in Patients with De Novo Metastatic Hormone-Sensitive Prostate Cancer. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Adding abiraterone to androgen deprivation therapy in men with metastatic hormone-sensitive prostate cancer: A systematic review and meta-analysis. [2023]

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Combination therapy for high-volume versus low-volume metastatic hormone-sensitive prostate cancer: A systematic review and network meta-analysis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Early Treatment Intensification in Metastatic Hormone-Sensitive Prostate Cancer. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Research protocol to identify progression and death amongst patients with metastatic hormone-sensitive prostate cancer treated with available treatments: PIONEER IMI's "big data for better outcomes" program. [2023]

6. Austria pubmed.ncbi.nlm.nih.gov

Is it possible to minimize overdrainage complications with gravitational units in patients with idiopathic normal pressure hydrocephalus? Protocol of the randomized controlled SVASONA Trial (ISRCTN51046698). [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

[Clinical experience with various shunt systems in normal pressure hydrocephalus]. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Performance of fixed-pressure valve with antisiphon device SPHERA(®) in hydrocephalus treatment and overdrainage prevention. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Performance of the fixed pressure valve with antisiphon device SPHERA® in the treatment of normal pressure hydrocephalus and prevention of overdrainage. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Outcomes and complications of different surgical treatments for idiopathic normal pressure hydrocephalus: a systematic review and meta-analysis. [2019]

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Ultra-low-pressure hydrocephalic state in NPH: benefits of therapeutic siphoning with adjustable antigravity valves. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Role of endoscopic third ventriculostomy and ventriculoperitoneal shunt in idiopathic normal pressure hydrocephalus: preliminary results of a randomized clinical trial. [2022]

13. Austria pubmed.ncbi.nlm.nih.gov

What is the appropriate shunt system for normal pressure hydrocephalus? [2016]

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[Clinical aspects and diagnostic difficulties in normotensive hydrocephalus]. [2015]

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Randomized trial of cerebrospinal fluid shunt valve design in pediatric hydrocephalus. [2022]