A Study Evaluate Aqueduct's Smart External Drain (SED)
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ClinicalTrials.gov Identifier: NCT03113799 |
Recruitment Status
:
Recruiting
First Posted
: April 14, 2017
Last Update Posted
: January 11, 2018
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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) |
Primary Purpose: | Treatment |
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 |
Arm | Intervention/treatment |
---|---|
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).
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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.
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- 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

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Ages Eligible for Study: | 5 Years to 80 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Stable Neuro - examination on standard EVD assessed as Not Clinically Significant (NCS) by PI or delegated Sub-I prior to study treatment.
- GCS > 13 (minimum of E3V5M5) prior to study treatment.
- 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)
- Age 5-80.
- 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)
- Able to perform and follow simple commands (ex: sit up in bed, lay down in bed)
- Pre-Study CT/MRI Imaging stable per PI Sub-I Assessment post ventriculostomy.
- Able to stand
- Able to obtain consent
Exclusion Criteria:
- Refractory ICP or needing active ICP management
- Unable to tolerate brief clamping of EVD (<5min)
- Unable to follow simple commands
- Unconscious
- Anticoagulant Therapy
- Known bleeding diathesis
- Scalp Infection
- In the opinion of the Investigator the subject is not a good study candidate

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
Contact: Karim Mohammed | 713-865-2156 | karim@tranquilconsulting.com |
United States, Washington | |
Seattle Children's Hospital | Recruiting |
Seattle, Washington, United States, 98105 | |
Contact: Amy Anderson amy.anderson2@seattlechildrens.org | |
Principal Investigator: Jeffrey Ojemann, MD | |
University of Washington School of Medicine / Harborview Medical Center | Recruiting |
Seattle, Washington, United States, 98195 | |
Contact: Amy Anderson amya9@uw.edu | |
Principal Investigator: Michael Levitt, MD | |
Sub-Investigator: A. Lele, MD |
Study Director: | Sam Browd, MD, PhD | Aqueduct Critical Care, Inc |
Responsible Party: | Aqueduct Critical Care |
ClinicalTrials.gov Identifier: | NCT03113799 History of Changes |
Other Study ID Numbers: |
ASSESSED SED1 |
First Posted: | April 14, 2017 Key Record Dates |
Last Update Posted: | January 11, 2018 |
Last Verified: | January 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | Yes | |
Device Product Not Approved or Cleared by U.S. FDA: | No | |
Pediatric Postmarket Surveillance of a Device Product: | No | |
Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
Hydrocephalus Brain Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms |