HydrocephalusNCT03471702
A Secondary Study Evaluating Aqueduct's Smart External Drain (SED)
A study testing Smart External Drain - SED in people with Hydrocephalus and Hydrocephalus in Children, run by Aqueduct Critical Care at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Hydrocephalus, Hydrocephalus in Children, Tumor, Brain
- What is being tested?
- Smart External Drain - SED
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Feb 2018to 1 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Texas Children's Hospital
Houston, Texas, 77030
Seattle Children's Hospital
Seattle, Washington, 98105
University of Washington School of Medicine, Harborview Medical Center
Seattle, Washington, 98195
About this study
Official title: 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
Read the detailed 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.
- Being tested
- Smart External Drain - SED
- Medical subject headings
- Hydrocephalus, Brain Neoplasms, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart External Drain - SEDDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Smart External Drain - SED |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Evaluating subject transport while on the SED system, specifically, the number of minutes a subject will require clamping of the drain while being transported.
Measured: 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.
SED system control will be evaluated from initiation of ICP management through discharge of the subject's external drain.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start28 Feb 2018
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Why it stopped: Device Review performed by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aqueduct Critical Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sam Browd, MD, PhD, Study director, Aqueduct Critical Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471702
- Sponsor's protocol ID
- ASSESSED SED2
- Status last verified
- Mar 2018
- First submitted
- 28 Feb 2018
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Secondary Study Evaluating Performance and Safety of Aqueduct's Smart External Drain (SED2)
- ClinicalTrials.gov ID
- NCT03471702
- Acronym / sponsor ID
- ASSESSED SED2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Device Review performed by Sponsor
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Aqueduct Critical CareIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study | Experimental | Device: Smart External Drain - SEDAll 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. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart External Drain - SEDAqueduct'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. | Device | Single Arm Study |
Primary outcome
The number of subjects which require switching to a standard of care external drain.
Time frame: 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.
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.
2 secondary outcomes
Subject transport while on the SED system.
Time frame: 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.
Time frame: 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.
Results and safety
The study was stopped early (reason given: Device Review performed by Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam Browd, MD, PhD study director
Aqueduct Critical Care, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart External Drain - SED in people with Hydrocephalus and Hydrocephalus in Children, run by Aqueduct Critical Care at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Device Review performed by Sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of subjects which require switching to a standard of care external drain. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.