A Study Evaluate Aqueduct's Smart External Drain (SED)
|ClinicalTrials.gov Identifier: NCT03113799|
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : January 11, 2018
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)|
|Estimated Enrollment :||75 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|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113799
|Contact: Karim Mohammedfirstname.lastname@example.org|
|United States, Washington|
|Seattle Children's Hospital||Recruiting|
|Seattle, Washington, United States, 98105|
|Contact: Amy Anderson email@example.com|
|Principal Investigator: Jeffrey Ojemann, MD|
|University of Washington School of Medicine / Harborview Medical Center||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Amy Anderson firstname.lastname@example.org|
|Principal Investigator: Michael Levitt, MD|
|Sub-Investigator: A. Lele, MD|
|Study Director:||Sam Browd, MD, PhD||Aqueduct Critical Care, Inc|