Clinical trial NCT03471702: A Secondary Study Evaluating Aqueduct's Smart External Drain (SED)
Official title: A Secondary Study Evaluating Performance and Safety of Aqueduct's Smart External Drain (SED2)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hydrocephalus
Hydrocephalus in Children
Tumor, Brain
Subarachnoid Hemorrhage
Lead sponsor: Aqueduct Critical Care
Sponsor class: INDUSTRY
First posted: 2018-03-21
Enrollment: 12
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: The number of subjects which require switching to a standard of care external drain.
timeFrame: 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.
Secondary outcomes:
measure: Subject transport while on the SED system.
timeFrame: 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.
measure: Evaluating SED system control throughout duration of study.
timeFrame: 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.
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Seattle
country: United States
facility: University of Washington School of Medicine, Harborview Medical Center
state: Washington
Study officials:
affiliation: Aqueduct Critical Care, Inc.
name: Sam Browd, MD, PhD
role: STUDY_DIRECTOR
References: