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

Aqueduct Critical Care

Status: Terminated

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

Treatments: Device: Smart External Drain - SED

Study type: Interventional

Funder types: Industry

Identifiers

NCT03471702

ASSESSED SED2

Details and patient eligibility

About

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

Full description

This clinical trial will evaluate Aqueduct's Smart External Drain (SED) upon implementation of ventriculostomy or lumbar drain placement for temporary CSF external management in a hospital setting. Subjects will remain on study from the time of SED application through discharge of the external drain or switch to standard of care extraventricular drain.

Enrollment: 12 patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Anticoagulant therapy (does not include DVT or PE prophylaxis).
2. Known bleeding diathesis.
3. Scalp infection.
4. In the opinion of the Investigator the subject is not a good study candidate.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Single Arm Study

Experimental group

Description:

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.

Treatment:

Device: Smart External Drain - SED