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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-28

Study Completion Date

2018-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Volume Optimization Incorporating Negative Pressure Diuresis in Heart Failure (VOID-HF)

NCT04227977

Cardiorenal Syndrome

COMPLETED NA

Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic Resistance

NCT01030185

Ascites

COMPLETED PHASE2/PHASE3

Fluid Responsiveness Evaluation in Sepsis-associated Hypotension

NCT02837731

Sepsis Hypotension

COMPLETED NA

A Feasibility Study of the Automated Fluid Shunt (AFS) for Automated Ascites Removal

NCT00870662

Refractory Ascites

COMPLETED NA

US Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus

NCT05232838

Hydrocephalus, Normal Pressure Hydrocephalus

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hydrocephalus Hydrocephalus in Children Tumor, Brain Subarachnoid Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single Arm Study

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.

Group Type EXPERIMENTAL

Smart External Drain - SED

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Smart External Drain - SED

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subject scheduled to have an external drain (includes extra-ventricular and lumbar drains) placed as part of routine management.
2. Age 0-80.
3. Able to obtain consent or legally authorized representative (LAR) consents for subject to be treated on study.

Exclusion Criteria

1. Anticoagulant therapy (does not include DVT or PE prophylaxis).
2. Known bleeding diathesis.
3. Scalp infection.
4. In the opinion of the Investigator the subject is not a good study candidate.

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No