A Secondary Study Evaluating Aqueduct's Smart External Drain (SED)
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer, Neurology, Women's Studies |
| Therapuetic Areas: | Neurology, Oncology, Reproductive |
| Healthy: | No |
| Age Range: | Any - 80 |
| Updated: | 4/17/2018 |
| Start Date: | February 28, 2018 |
| End Date: | June 1, 2019 |
| Contact: | Karim Mohammed |
| Email: | karim@tranquilconsulting.com |
| Phone: | 713-865-2156 |
A Secondary Study Evaluating Performance and Safety of Aqueduct's Smart External Drain (SED2)
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
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
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.
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.
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.
We found this trial at
3
sites
6621 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(832) 824-1000
Principal Investigator: William Whitehead, MD
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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4800 Sand Point Way NE
Seattle, Washington 98105
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Jeffrey Ojemann, MD
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Seattle, Washington 98104
Principal Investigator: Michael Levitt, MD
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