A Secondary Study Evaluating Aqueduct's Smart External Drain (SED)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03471702|
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : March 21, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
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
|Contact: Karim Mohammedfirstname.lastname@example.org|
|United States, Texas|
|Texas Children's Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Eric Sanchez email@example.com|
|Principal Investigator: William Whitehead, MD|
|United States, Washington|
|Seattle Children's Hospital||Recruiting|
|Seattle, Washington, United States, 98105|
|Contact: Amy Anderson firstname.lastname@example.org|
|Principal Investigator: Jeffrey Ojemann, MD|
|University of Washington School of Medicine, Harborview Medical Center||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Amy Anderson email@example.com|
|Principal Investigator: Michael Levitt, MD|
|Sub-Investigator: A. Lele, MD|
|Study Director:||Sam Browd, MD, PhD||Aqueduct Critical Care, Inc.|