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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
Sponsor:
Information provided by (Responsible Party):
Aqueduct Critical Care

Study Description
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Brief Summary:

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

Detailed Description:
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

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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).
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Staff interactions [ Time Frame: Two Days ]
    Average number of staff interactions per patient with standard EVD compared to intervention, the Smart External Drain (SED)


Secondary Outcome Measures :
  1. Staff Time [ Time Frame: Two Days ]
    Total minutes spent by staff interacting with standard EVD compared to SED

  2. Safety [ Time Frame: Two Days ]
    Number of Participants with Adverse Events That Are Related to Treatment


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
Contact: Karim Mohammed 713-865-2156 karim@tranquilconsulting.com

Locations
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         
Sponsors and Collaborators
Aqueduct Critical Care
Investigators
Study Director: Sam Browd, MD, PhD Aqueduct Critical Care, Inc
More Information
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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