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A Study Evaluate Aqueduct's Smart External Drain

NCT03113799 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2019-01-31

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Aqueduct Critical Care

    lead INDUSTRY

Principal Investigators

  • Sam Browd, MD, PhD · Aqueduct Critical Care, Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-12
Primary Completion
2018-08-15
Completion
2019-01-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03113799 on ClinicalTrials.gov