A Study Evaluate Aqueduct’s Smart External Drain

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Brief Title

A Study Evaluate Aqueduct's Smart External Drain

Official Title

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

Brief Summary

      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.
    

Detailed Description

      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
    


Study Type

Interventional


Primary Outcome

Staff interactions

Secondary Outcome

 Staff Time

Condition

Hydrocephalus

Intervention

Smart External Drain - SED

Study Arms / Comparison Groups

 Single Arm study
Description:  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).

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

56

Start Date

April 12, 2017

Completion Date

January 29, 2019

Primary Completion Date

August 15, 2018

Eligibility Criteria

        Inclusion Criteria:

          1. Stable Neuro - examination on standard EVD assessed as Not Clinically Significant
             (NCS) by PI or delegated Sub-I prior to study treatment.

          2. GCS > 13 (minimum of E3V5M5) prior to study treatment.

          3. Subject must be scheduled to have an EVD placed as part of routine management and for
             a length of at least 48 hours. (e.g. in the setting of a tumor removal or treatment of
             hydrocephalus)

          4. Age 5-80.

          5. Stable Vital Signs - Blood pressure (Systolic and Diastolic), Heart Rate, Respiratory
             Rate and weight assessed as not clinically significant (NCS) and afebrile as per
             PI/Sub-assessment. (Stable Vital signs will be re-assessed again prior to treatment
             with the SED on Day 2)

          6. Able to perform and follow simple commands (ex: sit up in bed, lay down in bed)

          7. Pre-Study CT/MRI Imaging stable per PI Sub-I Assessment post ventriculostomy.

          8. Able to stand

          9. Able to obtain consent

        Exclusion Criteria:

          1. Refractory ICP or needing active ICP management

          2. Unable to tolerate brief clamping of EVD (<5min)

          3. Unable to follow simple commands

          4. Unconscious

          5. Anticoagulant Therapy

          6. Known bleeding diathesis

          7. Scalp Infection

          8. In the opinion of the Investigator the subject is not a good study candidate
      

Gender

All

Ages

5 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Sam Browd, MD, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03113799

Organization ID

ASSESSED SED1


Responsible Party

Sponsor

Study Sponsor

Aqueduct Critical Care


Study Sponsor

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


Verification Date

January 2019