A Secondary Study Evaluating Aqueduct's Smart External Drain (SED)

NCT03471702 | Terminated FDA Device

• 1 other identifier: ASSESSED SED2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

Aqueduct's Smart External Drain (SED) will be compared to the current gold standard for temporary CSF management in a hospital setting.

• Evaluate the number of subjects requiring to be switched to a standard of care EVD
• Evaluate subject transport while on the SED
• Evaluate SED system control from initiation of SED through discharge of external drain system

Conditions

Hydrocephalus; Hydrocephalus in Children; Tumor, Brain; Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

• The number of subjects which require switching to a standard of care external drain.

  Evaluating the number of subjects which require switching to a standard of care external drain versus the number of subjects which remain on the SED until study completion or discharge of the external drain.

  The study review and data collection period will begin at the time SED is connected to the ventriculostomy catheter until discharge of ventriculostomy catheter; when subject no longer requires an external drain, assessed up to 90 days.

Secondary Outcomes (2)

• Subject transport while on the SED system.

  Subject transport review and data collection will begin when the patient is moved from their primary hospital bed location until they reach a new secondary location or are returned to the primary location. Assessed up to 90 days.

• Evaluating SED system control throughout duration of study.

  The study review and data collection period will begin at the time SED is connected to the ventriculostomy catheter until discharge of ventriculostomy catheter; when subject no longer requires an external drain, assessed up to 90 days.

Study Arms (1)

Single Arm Study

EXPERIMENTAL

All subjects enrolled on study will utilize Aqueduct's Smart External Drain (SED) from the time of external drain implementation until end of study upon discharge of SED or switch to standard of care external drain.

Device: Smart External Drain - SED

Interventions

Smart External Drain - SED DEVICE

Aqueduct's Smart External Drain (SED) is a gravity based system which utilizes a proprietary reference shroud which eliminates the need for manual adjustment of the system in the external management of CSF drainage.

Single Arm Study

Eligibility Criteria

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

You may qualify if:

• Subject scheduled to have an external drain (includes extra-ventricular and lumbar drains) placed as part of routine management.
• Age 0-80.
• Able to obtain consent or legally authorized representative (LAR) consents for subject to be treated on study.

You may not qualify if:

• Anticoagulant therapy (does not include DVT or PE prophylaxis).
• 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 (3)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

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; Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 21, 2018
• Study Start: February 28, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: July 11, 2019

Record last verified: 2018-03

Locations

US (3)