Neoplasms

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Heart and Blood Diseases

Neoplasm Metastasis

Hemorrhage

Subarachnoid Hemorrhage

Hydrocephalus

Brain Neoplasms

Intracranial Hemorrhages

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Vascular Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

All subjects enrolled on study will utilize Aqueduct's Smart External Drain (SED) from the time of external drain implementation until end of study upon discharge of SED or switch to standard of care external drain.

Aqueduct's Smart External Drain (SED) is a gravity based system which utilizes a proprietary reference shroud which eliminates the need for manual adjustment of the system in the external management of CSF drainage.

Smart External Drain - SED

Sam Browd, MD, PhD

Aqueduct's Smart External Drain (SED) will be compared to the current gold standard for temporary CSF management in a hospital setting.

* Evaluate the number of subjects requiring to be switched to a standard of care EVD
* Evaluate subject transport while on the SED
* Evaluate SED system control from initiation of SED through discharge of external drain system

This clinical trial will evaluate Aqueduct's Smart External Drain (SED) upon implementation of ventriculostomy or lumbar drain placement for temporary CSF external management in a hospital setting. Subjects will remain on study from the time of SED application through discharge of the external drain or switch to standard of care extraventricular drain.

A Secondary Study Evaluating Aqueduct's Smart External Drain (SED)

A Secondary Study Evaluating Performance and Safety of Aqueduct's Smart External Drain (SED2)

Evaluating the number of subjects which require switching to a standard of care external drain versus the number of subjects which remain on the SED until study completion or discharge of the external drain.

Evaluating subject transport while on the SED system, specifically, the number of minutes a subject will require clamping of the drain while being transported.

SED system control will be evaluated from initiation of ICP management through discharge of the subject's external drain.

Aqueduct Critical Care

Single Arm study In this study, the subject will act as their own control. On Day 1 of the two day study, the subject will be observed while treated on their standard EVD. On Day 2, the subject will be treated with the Smart External Drain (SED).

Subject will be treated on Day 2 with the SED. ICP and CSF volumes will be recorded at prespecified intervals while subject is stationary and while subject is engaged in protocol-driven directed movements.

To evaluate the performance characteristics of the Smart External Drain (SED) compared with standard EVD drains in the hospital setting, specifically:

* Number, type and duration of staff interactions.
* Regulating and controlling ICP and CSF drainage.
* Maintaining system control with patient movement.

In this two day clinical trial, subjects will be observed on Day 1 of study during their routine treatment and using their already existing EVD. On Day 2 of study; subjects will be switched to the Smart External Drain for monitoring and management of ICP and CSF

In this study the subject will act as their own control and will be treated on day one with the standard of care EVD and then on Day 2 treated with the SED.

A Study Evaluate Aqueduct's Smart External Drain

A Study to Evaluate the Performance and Safety of Aqueduct's Smart External Device (SED) Compared to Standard EVD Drains

Average number of staff interactions per patient with standard EVD compared to intervention, the Smart External Drain (SED)

Total minutes spent by staff interacting with standard EVD compared to SED

Number of Participants with Adverse Events That Are Related to Treatment

Rare Diseases

Hypertension

Stroke

Intracranial Hypertension

Pseudotumor Cerebri

Hydrocephalus, Normal Pressure

Hemorrhagic Stroke

Idiopathic Intracranial Hypertension

CODMAN CERTAS Plus Programmable Valve, CODMAN CERTAS Plus Small Inline Programmable Valve, and CODMAN CERTAS Plus Right Angle Programmable Valve.

Patients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.

CODMAN CERTAS Plus Programmable Valve

Maria Salmon-Sargeant

Andrew Tummon

Dimitri Vanhauwaert, MD

Stijn Van Damme, SC

Dr. Oliver Müller

Thomas Beez, MD

Fljamur Aljiji, SC

Dr. Philipp Dammann

Dr. Mukesch Johannes Shah

Dr. Oliver Gandslandt

Sherese Fralin, MSN, FNP, PhD

Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.

The CODMAN CERTAS Plus Programmable Valve is a single use implantable device designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus.

The valve can be set to 8 different performance settings for intraventricular pressure and drainage of CSF. The performance setting of the valve can be set preoperatively and can also be noninvasively changed post-implantation.

This clinical investigation will maintain data for each patient from the date of implant through 3 years post-implantation.

Data collection for each patient will occur per standard of care.

However, the clinical investigation specifically aims to collect and analyze data from the day of procedure, and post-operatively at 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months.

Data from follow-up visits will be analyzed according to pre-defined time-intervals referring to these follow-up moments.

Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve

Post-Market Clinical Follow-up of Patients With CODMAN CERTAS Plus Programmable Valve

Incidence of Valve replacement post - implantation

Incidence of Adverse Events post - implantation

Long term safety will be assessed by the incidence of all adverse events/complications including number of subjects with shunt and/or shunt system infections.

Incidence of inadvertent reprogramming of CODMAN CERTAS Plus Programmable Valves post - implantation prior to MRI

Device Success is defined as:

1. Deployment with the correct valve positioning
2. Original intended device in place, and
3. No additional surgical or interventional procedures related to access or the device since completion of the original procedure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Secondary Study Evaluating Aqueduct's Smart External Drain (SED)	NCT03471702	Hydrocephalus Hydrocephalus i... Tumor, Brain Subarachnoid He...	Smart External ...	- 80 Years	Aqueduct Critical Care
A Study Evaluate Aqueduct's Smart External Drain	NCT03113799	Hydrocephalus Hydrocephalus i... Tumor, Brain	Smart External ...	5 Years - 80 Years	Aqueduct Critical Care
A Study Evaluate Aqueduct's Smart External Drain	NCT03113799	Hydrocephalus Hydrocephalus i... Tumor, Brain	Smart External ...	5 Years - 80 Years	Aqueduct Critical Care
Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve	NCT05397106	Hydrocephalus Hydrocephalus i... NPH (Normal Pre... IIH - Idiopathi... Brain Tumor Post-Traumatic ... Hemorrhagic Str...	CODMAN CERTAS P...	-	Integra LifeSciences Corporation
Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve	NCT05397106	Hydrocephalus Hydrocephalus i... NPH (Normal Pre... IIH - Idiopathi... Brain Tumor Post-Traumatic ... Hemorrhagic Str...	CODMAN CERTAS P...	-	Integra LifeSciences Corporation

Spots Global Cancer Trial Database for hydrocephalus in children