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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03471702
Other study ID # ASSESSED SED2
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 28, 2018
Est. completion date November 1, 2018

Study information

Verified date March 2018
Source Aqueduct Critical Care
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 12
Est. completion date November 1, 2018
Est. primary completion date November 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 80 Years
Eligibility 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.

Study Design


Intervention

Device:
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.

Locations

Country Name City State
United States Texas Children's Hospital Houston Texas
United States Seattle Children's Hospital Seattle Washington
United States University of Washington School of Medicine, Harborview Medical Center Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Aqueduct Critical Care

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The number of subjects which require switching to a standard of care external drain. 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. The study review and data collection period will begin at the time SED is connected to the ventriculostomy catheter until discharge of ventriculostomy catheter; when subject no longer requires an external drain, assessed up to 90 days.
Secondary Subject transport while on the SED system. Evaluating subject transport while on the SED system, specifically, the number of minutes a subject will require clamping of the drain while being transported. Subject transport review and data collection will begin when the patient is moved from their primary hospital bed location until they reach a new secondary location or are returned to the primary location. Assessed up to 90 days.
Secondary Evaluating SED system control throughout duration of study. SED system control will be evaluated from initiation of ICP management through discharge of the subject's external drain. The study review and data collection period will begin at the time SED is connected to the ventriculostomy catheter until discharge of ventriculostomy catheter; when subject no longer requires an external drain, assessed up to 90 days.
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