A Study Evaluate Aqueduct's Smart External Drain (SED)
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|ClinicalTrials.gov Identifier: NCT03113799|
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : January 31, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Hydrocephalus Hydrocephalus in Children Tumor, Brain||Device: Smart External Drain - SED||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||In this study the subject will act as their own control and will be treated on day one with the standard of care EVD and then on Day 2 treated with the SED.|
|Masking:||None (Open Label)|
|Official Title:||A Study to Evaluate the Performance and Safety of Aqueduct's Smart External Device (SED) Compared to Standard EVD Drains|
|Actual Study Start Date :||April 12, 2017|
|Actual Primary Completion Date :||August 15, 2018|
|Actual Study Completion Date :||January 29, 2019|
Single Arm study
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).
Device: Smart External Drain - SED
Subject will be treated on Day 2 with the SED. ICP and CSF volumes will be recorded at prespecified intervals while subject is stationary and while subject is engaged in protocol-driven directed movements.
- Staff interactions [ Time Frame: Two Days ]Average number of staff interactions per patient with standard EVD compared to intervention, the Smart External Drain (SED)
- Staff Time [ Time Frame: Two Days ]Total minutes spent by staff interacting with standard EVD compared to SED
- Safety [ Time Frame: Two Days ]Number of Participants with Adverse Events That Are Related to Treatment
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): NCT03113799
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|University of Washington School of Medicine / Harborview Medical Center|
|Seattle, Washington, United States, 98195|
|Study Director:||Sam Browd, MD, PhD||Aqueduct Critical Care, Inc|