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

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Brief Title

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

Official Title

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

Brief 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
    

Detailed 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.
    


Study Type

Interventional


Primary Outcome

The number of subjects which require switching to a standard of care external drain.

Secondary Outcome

 Subject transport while on the SED system.

Condition

Hydrocephalus

Intervention

Smart External Drain - SED

Study Arms / Comparison Groups

 Single Arm Study
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

12

Start Date

February 28, 2018

Completion Date

November 1, 2018

Primary Completion Date

November 1, 2018

Eligibility Criteria

        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.
      

Gender

All

Ages

N/A - 80 Years

Accepts Healthy Volunteers

No

Contacts

Sam Browd, MD, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03471702

Organization ID

ASSESSED SED2


Responsible Party

Sponsor

Study Sponsor

Aqueduct Critical Care


Study Sponsor

Sam Browd, MD, PhD, Study Director, Aqueduct Critical Care, Inc.


Verification Date

March 2018