A Study Evaluate Aqueduct's Smart External Drain (SED)

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.

Study Overview

• Status: Completed
• Conditions: Hydrocephalus; Hydrocephalus in Children; Tumor, Brain
• Intervention / Treatment: Device: Smart External Drain - SED

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital
    • Seattle, Washington, United States, 98195
      • University of Washington School of Medicine / Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 78 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Staff interactions	Average number of staff interactions per patient with standard EVD compared to intervention, the Smart External Drain (SED)	Two Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Staff Time	Total minutes spent by staff interacting with standard EVD compared to SED	Two Days
Safety	Number of Participants with Adverse Events That Are Related to Treatment	Two Days

Collaborators and Investigators

• Sponsor: Aqueduct Critical Care
• Investigators: Study Director: Sam Browd, MD, PhD, Aqueduct Critical Care, Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2017
• Primary Completion (Actual): August 15, 2018
• Study Completion (Actual): January 29, 2019

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms; Hydrocephalus
• Other Study ID Numbers: ASSESSED SED1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No