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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

March 20, 2017
April 14, 2017
January 11, 2018
April 12, 2017
December 2018   (Final data collection date for primary outcome measure)
Staff interactions [ Time Frame: Two Days ]
Average number of staff interactions per patient with standard EVD compared to intervention, the Smart External Drain (SED)
Same as current
Complete list of historical versions of study NCT03113799 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Study Evaluate Aqueduct's Smart External Drain
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.
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
Interventional
Not Applicable
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
  • Hydrocephalus
  • Hydrocephalus in Children
  • Tumor, Brain
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.
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).
Intervention: Device: Smart External Drain - SED
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
Same as current
December 2018
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
5 Years to 80 Years   (Child, Adult, Senior)
No
Contact: Karim Mohammed 713-865-2156 karim@tranquilconsulting.com
United States
 
 
NCT03113799
ASSESSED SED1
No
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
Plan to Share IPD: Undecided
Aqueduct Critical Care
Aqueduct Critical Care
Not Provided
Study Director: Sam Browd, MD, PhD Aqueduct Critical Care, Inc
Aqueduct Critical Care
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP