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Trial record 20 of 30 for:    Recruiting, Not yet recruiting, Available Studies | "Hydrocephalus"

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

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ClinicalTrials.gov Identifier: NCT03471702
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Aqueduct Critical Care

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

Condition or disease Intervention/treatment Phase
Hydrocephalus Hydrocephalus in Children Tumor, Brain Subarachnoid Hemorrhage Device: Smart External Drain - SED Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Secondary Study Evaluating Performance and Safety of Aqueduct's Smart External Drain (SED2)
Actual Study Start Date : February 28, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. The number of subjects which require switching to a standard of care external drain. [ Time Frame: 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. ]
    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.


Secondary Outcome Measures :
  1. Subject transport while on the SED system. [ Time Frame: 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. ]
    Evaluating subject transport while on the SED system, specifically, the number of minutes a subject will require clamping of the drain while being transported.

  2. Evaluating SED system control throughout duration of study. [ Time Frame: 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. ]
    SED system control will be evaluated from initiation of ICP management through discharge of the subject's external drain.



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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471702


Contacts
Contact: Karim Mohammed 713-865-2156 karim@tranquilconsulting.com

Locations
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Eric Sanchez       easanche@texaschildrens.org   
Principal Investigator: William Whitehead, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Amy Anderson       amy.anderson2@seattlechildrens.org   
Principal Investigator: Jeffrey Ojemann, MD         
University of Washington School of Medicine, Harborview Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Amy Anderson       amya9@uw.edu   
Principal Investigator: Michael Levitt, MD         
Sub-Investigator: A. Lele, MD         
Sponsors and Collaborators
Aqueduct Critical Care
Investigators
Study Director: Sam Browd, MD, PhD Aqueduct Critical Care, Inc.

Responsible Party: Aqueduct Critical Care
ClinicalTrials.gov Identifier: NCT03471702     History of Changes
Other Study ID Numbers: ASSESSED SED2
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Hydrocephalus
Hemorrhage
Subarachnoid Hemorrhage
Brain Neoplasms
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms