A Study Evaluate Aqueduct's Smart External Drain



Status:Completed
Conditions:Brain Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:5 - 80
Updated:2/2/2019
Start Date:April 12, 2017
End Date:January 29, 2019

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A Study to Evaluate the Performance and Safety of Aqueduct's Smart External Device (SED) Compared to Standard EVD Drains

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.

In this two day clinical trial, subjects will be observed on Day 1 of study during their
routine treatment and using their already existing EVD. On Day 2 of study; subjects will be
switched to the Smart External Drain for monitoring and management of ICP and CSF

Inclusion Criteria:

1. Stable Neuro - examination on standard EVD assessed as Not Clinically Significant
(NCS) by PI or delegated Sub-I prior to study treatment.

2. GCS > 13 (minimum of E3V5M5) prior to study treatment.

3. Subject must be scheduled to have an EVD placed as part of routine management and for
a length of at least 48 hours. (e.g. in the setting of a tumor removal or treatment of
hydrocephalus)

4. Age 5-80.

5. Stable Vital Signs - Blood pressure (Systolic and Diastolic), Heart Rate, Respiratory
Rate and weight assessed as not clinically significant (NCS) and afebrile as per
PI/Sub-assessment. (Stable Vital signs will be re-assessed again prior to treatment
with the SED on Day 2)

6. Able to perform and follow simple commands (ex: sit up in bed, lay down in bed)

7. Pre-Study CT/MRI Imaging stable per PI Sub-I Assessment post ventriculostomy.

8. Able to stand

9. Able to obtain consent

Exclusion Criteria:

1. Refractory ICP or needing active ICP management

2. Unable to tolerate brief clamping of EVD (<5min)

3. Unable to follow simple commands

4. Unconscious

5. Anticoagulant Therapy

6. Known bleeding diathesis

7. Scalp Infection

8. In the opinion of the Investigator the subject is not a good study candidate
We found this trial at
2
sites
4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Jeffrey Ojemann, MD
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Seattle, Washington 98104
Principal Investigator: Michael Levitt, MD
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