Hydrocephalus, Normal PressureNCT05232838
US Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
A study testing eShunt Implant in people with Hydrocephalus, Normal Pressure and Hydrocephalus, run by CereVasc Inc at 11 sites in United States.
Trial summary
The eShunt® System is a minimally invasive method of treating communicating hydrocephalus. The eShunt System includes a proprietary eShunt Delivery System and the eShunt Implant, a permanent implant deployed in a minimally invasive, neuro-interventional procedure. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Hydrocephalus, Normal Pressure, Hydrocephalus
- What is being tested?
- eShunt Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 11 sitesUnited States
- Study dates
- 20 Apr 2022to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients 65-85 years old for whom traditional CSF shunt placement is indicated based upon a diagnostic normal pressure hydrocephalus (NPH) evaluation
- Patient or legally authorized representative is able and willing to provide written informed consent
- History or evidence of gait impairment duration ≥6 months
- Clinical presentation consistent with NPH including 2 or more of the clinical triad (i.e., history of gait disturbance, progressive mental deterioration, and urinary urgency or incontinence), together with:
- Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans' Index >0.3) and the absence of severe hippocampal atrophy
- Pre-procedure spinal tap test or lumbar drain with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%
Show all 10Show fewer
- CSF opening pressure ≥8 cmH2O
- Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12
- 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)
- Pre-procedure CT confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by SSC
Who cannot join
- Unable to walk 10 meters (33 feet) with or without an assistive device
- Signs or symptoms of obstructive hydrocephalus
- Active systemic infection or infection detected in CSF
- Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
- Hypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available
- Occlusion or stenosis of the internal jugular vein
Show all 17Show fewer
- Venous distension in the neck on physical exam
- Atrial septal defect or patent foramen ovale identified on cardiac echocardiogram
- History of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency
- Stroke or transient ischemic attack within 180 days of eShunt Procedure
- Presence of a deep vein thrombosis superior to the popliteal vein
- International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results outside of normal range (INR 0.8-1.4; PTT 25-35 seconds)
- Presence of a posterior fossa tumor or mass
- Life expectancy < 1 year
- Currently participating in another investigational drug or device trial that could conflict with study data collection or follow-up
- Other medical illnesses that may cause the patient to be non-compliant with the protocol or confound data interpretation
- Unwilling or unable to comply with follow-up requirements
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University at Buffalo,
Buffalo, New York, 14203
Baptist Health
Jacksonville, Florida, 32207
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Kentucky Research Foundation
Lexington, Kentucky, 40506
Yale University
New Haven, Connecticut, 06511
NYU Langone Health
New York, New York, 10016
Rhode Island Hospital
Providence, Rhode Island, 02903
Virginia Commonwealth University
Richmond, Virginia, 23219
University of Rochester Medical Center
Rochester, New York, 14642
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: US Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus
The eShunt® System is a minimally invasive method of treating communicating hydrocephalus. The eShunt System includes a proprietary eShunt Delivery System and the eShunt Implant, a permanent implant deployed in a minimally invasive, neuro-interventional procedure. The eShunt System is intended to shunt cerebrospinal fluid from the intracranial subarachnoid space to the venous system for the treatment of patients with normal pressure hydrocephalus, reducing disability due to symptoms including one or more of gait disturbance, cognitive dysfunction and urinary incontinence.
Read the detailed description
This is a prospective, non-randomized, open-label, multi-center, pilot study in subjects with normal pressure hydrocephalus for whom a traditional cerebrospinal fluid (CSF) shunt implant is indicated.
Up to 50 subjects will receive the eShunt Implant at up to 12 investigational sites. It is anticipated that up to 250 patients may need to be enrolled (consented) in order to result in 50 subjects who qualify according to the inclusion/exclusion criteria. Subjects will return for five follow-up visits in the first year and then continue to attend visits every six months until the study is closed or up to five years post-implantation.
The study objectives are to demonstrate safety of the eShunt Procedure, as well as demonstrate safety and efficacy of the eShunt Implant in a small sample of patients. Subjects will be followed long-term; primary analysis results will be used to support additional studies.
- Conditions
- Hydrocephalus, Normal Pressure, Hydrocephalus
- Being tested
- eShunt Implant
- Keywords
- eShunt, Minimally invasive shunt, Endovascular shunt
- Medical subject headings
- Hydrocephalus, Normal Pressure, Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eShunt ImplantDevice
The eShunt System is intended to shunt cerebrospinal fluid from the intracranial subarachnoid space to the venous system for the treatment of patients with normal pressure hydrocephalus, reducing disability due to symptoms including one or more of gait disturbance, cognitive dysfunction and urinary incontinence.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | The Treatment Arm receives the eShunt Implant. Receives: Device: eShunt Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device and/or procedure-related serious adverse events (SAEs)
Rate of occurrence of device and/or procedure-related serious adverse events (SAEs)
Measured: 90 days following eShunt Implant deployment
Secondary outcomes (10)
Number of participants with abnormal MRI findings
Number of participants with abnormal MRI findings and descriptive summaries of findings
Measured: 90 days following eShunt Implant deployment
Number of participants with abnormal CT findings
Number of participants with abnormal CT findings and descriptive summaries of findings
Measured: 90 days following eShunt Implant deployment
Number of participants with clinically significant abnormal complete blood count (CBC) results
Number of participants with clinically significant abnormal results and descriptive summaries of CBC results
Measured: 90, 180, and 365 days following eShunt Implant deployment
Number of participants with clinically significant abnormal blood chemistry results
Number of participants with clinically significant abnormal findings and descriptive summaries of blood chemistry results
Measured: 90, 180, and 365 days following eShunt Implant deployment
Number of participants with clinically significant abnormal neurological exam findings
Number of participants with clinically significant abnormal findings and descriptive summaries of neurological exam findings
Measured: 90, 180, and 365 days following eShunt Implant deployment and at study completion
Number of participants with adverse events
Tabulation of all adverse events
Measured: 90, 180 and 365 days following eShunt Implant deployment and at study completion
Change in gait compared to baseline
Change in gait compared to baseline as measured by the duration in seconds of the Timed Up and Go Test (shorter durations indicate improvement (increased mobility))
Measured: 90, 180 and 365 days following eShunt Implant deployment
Change in cognitive ability compared to baseline
Change in cognitive ability compared to baseline as measured by Montreal Cognitive Assessment (MoCA) scores (scores range from 0-30; higher scores indicate improvement (less cognitive disability))
Measured: 90, 180 and 365 days following eShunt Implant deployment
Change in urinary symptoms compared to baseline
Change in urinary symptoms compared to baseline as measured by the Neurogenic Bladder Symptom Score (NBSS) (scores range from 0-28; lower scores indicate improvement (fewer symptoms))
Measured: 90, 180 and 365 days following eShunt Implant deployment
Change in Modified Rankin Scale compared to baseline
Change in degree of disability compared to baseline as measured by Modified Rankin Scale (mRS) scores (scores range from 0-6; lower scores indicate improvement (less disability))
Measured: 90, 180 and 365 days following eShunt Implant deployment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start20 Apr 2022
- Primary completion15 Jun 2025
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hydrocephalus, Normal PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CereVasc Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AlvaMed, Inc., Simplified Clinical Data Systems, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232838
- Sponsor's protocol ID
- CLIN-0016
- Status last verified
- Jun 2025
- First submitted
- 6 Jan 2022
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Heilman CB, Basil GW, Beneduce BM, Malek AM. Anatomical characterization of the inferior petrosal sinus and adjacent cerebellopontine angle cistern for development of an endovascular transdural cerebrospinal fluid shunt. J Neurointerv Surg. 2019 Jun;11(6):598-602. doi: 10.1136/neurintsurg-2018-014445. Epub 2019 Jan 9.
PubMed 30626626Lylyk P, Lylyk I, Bleise C, Scrivano E, Lylyk PN, Beneduce B, Heilman CB, Malek AM. First-in-human endovascular treatment of hydrocephalus with a miniature biomimetic transdural shunt. J Neurointerv Surg. 2022 May;14(5):495-9. doi: 10.1136/neurintsurg-2021-018136. Epub 2021 Dec 3.
PubMed 34862267Welk B, Morrow S, Madarasz W, Baverstock R, Macnab J, Sequeira K. The validity and reliability of the neurogenic bladder symptom score. J Urol. 2014 Aug;192(2):452-7. doi: 10.1016/j.juro.2014.01.027. Epub 2014 Feb 8.
PubMed 24518764Welk B, Lenherr S, Elliott S, Stoffel J, Gomes CM, de Bessa J, Cintra LKL, Myers JB; Neurogenic Bladder Research Group. The creation and validation of a short form of the Neurogenic Bladder Symptom Score. Neurourol Urodyn. 2020 Apr;39(4):1162-1169. doi: 10.1002/nau.24336. Epub 2020 Mar 20.
PubMed 32196732Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
PubMed 15817019Lylyk P, Matouk CC, Hanel RA, Reavey-Cantwell JF, Riina HA, Altschul DJ, Siddiqui AH, Fraser JF, Ebersole KC, Bhalla T, Bender MT, Ogilvy CS, Taussky P, Baker A, Jayaraman MV, Lylyk I, Perez N, Bleise C, Scrivano E, Lylyk PN, Nowicki KW, Koo AB, Antonios J, Beneduce BM, Levy EI, Heilman CB, Malek AM. Safety of endovascular shunting for normal pressure hydrocephalus from a prospective, multicenter, single-arm study. J Neurointerv Surg. 2026 Jun 17:jnis-2025-024702. doi: 10.1136/jnis-2025-024702. Online ahead of print.
PubMed 41734937Amllay A, Matouk CC. A Paradigm Shift in Hydrocephalus Management: The Promise of Endovascular Cerebrospinal Fluid Diversion. Cardiol Rev. 2025 Jul-Aug 01;33(4):294-297. doi: 10.1097/CRD.0000000000000886. Epub 2025 Mar 26.
PubMed 40135887
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- US Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus
- ClinicalTrials.gov ID
- NCT05232838
- Acronym / sponsor ID
- CLIN-0016
- Conditions
- Hydrocephalus, Normal Pressure, Hydrocephalus
- Keywords
- eShunt, Minimally invasive shunt, Endovascular shunt
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CereVasc IncIndustry (pharma, biotech, devices)
- Collaborators
- AlvaMed, Inc., Simplified Clinical Data Systems, LLC
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The eShunt® System is a minimally invasive method of treating communicating hydrocephalus. The eShunt System includes a proprietary eShunt Delivery System and the eShunt Implant, a permanent implant deployed in a minimally invasive, neuro-interventional procedure. The eShunt System is intended to shunt cerebrospinal fluid from the intracranial subarachnoid space to the venous system for the treatment of patients with normal pressure hydrocephalus, reducing disability due to symptoms including one or more of gait disturbance, cognitive dysfunction and urinary incontinence.
Detailed description
This is a prospective, non-randomized, open-label, multi-center, pilot study in subjects with normal pressure hydrocephalus for whom a traditional cerebrospinal fluid (CSF) shunt implant is indicated.
Up to 50 subjects will receive the eShunt Implant at up to 12 investigational sites. It is anticipated that up to 250 patients may need to be enrolled (consented) in order to result in 50 subjects who qualify according to the inclusion/exclusion criteria. Subjects will return for five follow-up visits in the first year and then continue to attend visits every six months until the study is closed or up to five years post-implantation.
The study objectives are to demonstrate safety of the eShunt Procedure, as well as demonstrate safety and efficacy of the eShunt Implant in a small sample of patients. Subjects will be followed long-term; primary analysis results will be used to support additional studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: eShunt ImplantThe Treatment Arm receives the eShunt Implant. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Patients 65-85 years old for whom traditional CSF shunt placement is indicated based upon a diagnostic normal pressure hydrocephalus (NPH) evaluation
- Patient or legally authorized representative is able and willing to provide written informed consent
- History or evidence of gait impairment duration ≥6 months
- Clinical presentation consistent with NPH including 2 or more of the clinical triad (i.e., history of gait disturbance, progressive mental deterioration, and urinary urgency or incontinence), together with:
- 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)
Key exclusion criteria (17 listed)
- Unable to walk 10 meters (33 feet) with or without an assistive device
- Signs or symptoms of obstructive hydrocephalus
- Active systemic infection or infection detected in CSF
- Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
- Hypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eShunt ImplantThe eShunt System is intended to shunt cerebrospinal fluid from the intracranial subarachnoid space to the venous system for the treatment of patients with normal pressure hydrocephalus, reducing disability due to symptoms including one or more of gait disturbance, cognitive dysfunction and urinary incontinence. | Device | Treatment Arm |
Primary outcome
Device and/or procedure-related serious adverse events (SAEs)
Time frame: 90 days following eShunt Implant deployment
Rate of occurrence of device and/or procedure-related serious adverse events (SAEs)
10 secondary outcomes
Number of participants with abnormal MRI findings
Time frame: 90 days following eShunt Implant deployment
Number of participants with abnormal CT findings
Time frame: 90 days following eShunt Implant deployment
Number of participants with clinically significant abnormal complete blood count (CBC) results
Time frame: 90, 180, and 365 days following eShunt Implant deployment
Number of participants with clinically significant abnormal blood chemistry results
Time frame: 90, 180, and 365 days following eShunt Implant deployment
Number of participants with clinically significant abnormal neurological exam findings
Time frame: 90, 180, and 365 days following eShunt Implant deployment and at study completion
Number of participants with adverse events
Time frame: 90, 180 and 365 days following eShunt Implant deployment and at study completion
Change in gait compared to baseline
Time frame: 90, 180 and 365 days following eShunt Implant deployment
Change in cognitive ability compared to baseline
Time frame: 90, 180 and 365 days following eShunt Implant deployment
Change in urinary symptoms compared to baseline
Time frame: 90, 180 and 365 days following eShunt Implant deployment
Change in Modified Rankin Scale compared to baseline
Time frame: 90, 180 and 365 days following eShunt Implant deployment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Background: PubMed 30626626Heilman CB, Basil GW, Beneduce BM, Malek AM. Anatomical characterization of the inferior petrosal sinus and adjacent cerebellopontine angle cistern for development of an endovascular transdural cerebrospinal fluid shunt. J Neurointerv Surg. 2019 Jun;11(6):598-602. doi: 10.1136/neurintsurg-2018-014445. Epub 2019 Jan 9.
- Background: PubMed 34862267Lylyk P, Lylyk I, Bleise C, Scrivano E, Lylyk PN, Beneduce B, Heilman CB, Malek AM. First-in-human endovascular treatment of hydrocephalus with a miniature biomimetic transdural shunt. J Neurointerv Surg. 2022 May;14(5):495-9. doi: 10.1136/neurintsurg-2021-018136. Epub 2021 Dec 3.
- Background: PubMed 24518764Welk B, Morrow S, Madarasz W, Baverstock R, Macnab J, Sequeira K. The validity and reliability of the neurogenic bladder symptom score. J Urol. 2014 Aug;192(2):452-7. doi: 10.1016/j.juro.2014.01.027. Epub 2014 Feb 8.
- Background: PubMed 32196732Welk B, Lenherr S, Elliott S, Stoffel J, Gomes CM, de Bessa J, Cintra LKL, Myers JB; Neurogenic Bladder Research Group. The creation and validation of a short form of the Neurogenic Bladder Symptom Score. Neurourol Urodyn. 2020 Apr;39(4):1162-1169. doi: 10.1002/nau.24336. Epub 2020 Mar 20.
- Background: PubMed 15817019Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
- Derived from this study: PubMed 41734937Lylyk P, Matouk CC, Hanel RA, Reavey-Cantwell JF, Riina HA, Altschul DJ, Siddiqui AH, Fraser JF, Ebersole KC, Bhalla T, Bender MT, Ogilvy CS, Taussky P, Baker A, Jayaraman MV, Lylyk I, Perez N, Bleise C, Scrivano E, Lylyk PN, Nowicki KW, Koo AB, Antonios J, Beneduce BM, Levy EI, Heilman CB, Malek AM. Safety of endovascular shunting for normal pressure hydrocephalus from a prospective, multicenter, single-arm study. J Neurointerv Surg. 2026 Jun 17:jnis-2025-024702. doi: 10.1136/jnis-2025-024702. Online ahead of print.
- Derived from this study: PubMed 40135887Amllay A, Matouk CC. A Paradigm Shift in Hydrocephalus Management: The Promise of Endovascular Cerebrospinal Fluid Diversion. Cardiol Rev. 2025 Jul-Aug 01;33(4):294-297. doi: 10.1097/CRD.0000000000000886. Epub 2025 Mar 26.
- Individual participant dataSharing planned: No
Related trials for Hydrocephalus, Normal Pressure
Not yet recruitingObservational study
Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Using Radscale and Lumbar Puncture
Idiopathic Normal Pressure Hydrocephalus, Normal Pressure Hydrocephalus
Recruiting
Analysis of Cerebrospinal Fluid Dynamics in Normal Pressure Hydrocephalus
Normal Pressure Hydrocephalus
Active, not recruiting
Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
Normal Pressure Hydrocephalus
Recruiting
Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials
NPH (Normal Pressure Hydrocephalus)
RecruitingObservational study
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
Hydrocephalus, Normal Pressure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eShunt Implant in people with Hydrocephalus, Normal Pressure and Hydrocephalus, run by CereVasc Inc at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device and/or procedure-related serious adverse events (SAEs) (time frame: 90 days following eShunt Implant deployment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05232838, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.