A Study Evaluate Aqueduct's Smart External Drain

NCT03113799 | Completed FDA Device

• 1 other identifier: ASSESSED SED1
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

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.

Conditions

Hydrocephalus; Hydrocephalus in Children; Tumor, Brain

Outcome Measures

Primary Outcomes (1)

• Staff interactions

  Average number of staff interactions per patient with standard EVD compared to intervention, the Smart External Drain (SED)

  Two Days

Secondary Outcomes (2)

• Staff Time

  Two Days

• Safety

  Two Days

Study Arms (1)

Single Arm study

OTHER

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

Interventions

Smart External Drain - SED DEVICE

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.

Single Arm study

Eligibility Criteria

• Age: 5 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aqueduct Critical Care: lead

Study Sites (2)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

University of Washington School of Medicine / Harborview Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Hydrocephalus; Brain Neoplasms

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Sam Browd, MD, PhD

  Aqueduct Critical Care, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: April 14, 2017
• Study Start: April 12, 2017
• Primary Completion: August 15, 2018
• Study Completion: January 29, 2019
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

US (2)