An interventional study of Smart External Drain - SED in Hydrocephalus, Hydrocephalus in Children and Tumor, Brain, sponsored by Aqueduct Critical Care. Terminated at 3 sites in United States. Open to participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2019-07-11.
Sponsored by Aqueduct Critical Care · Not applicable, Interventional, and Treatment
Aqueduct's Smart External Drain (SED) will be compared to the current gold standard for temporary CSF management in a hospital setting.
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.
190 studies on the registry are indexed under Hydrocephalus; 52 are open to participants now.
This study's enrollment of 12 is below the median of 41 across 97 interventional studies indexed under Hydrocephalus.
Browse Hydrocephalus studies →Aqueduct Critical Care is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
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.
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.
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.
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 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.
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.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Nov 2018, 8 months.
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This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Aqueduct Critical Care