HydrocephalusSEDNCT03113799
A Study Evaluate Aqueduct's Smart External Drain
A study testing Smart External Drain - SED in people with Hydrocephalus and Hydrocephalus in Children, run by Aqueduct Critical Care at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 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
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Apr 2017to 29 Jan 2019
- 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 5 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stable Neuro - examination on standard EVD assessed as Not Clinically Significant (NCS) by PI or delegated Sub-I prior to study treatment.
- GCS > 13 (minimum of E3V5M5) prior to study treatment.
- 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)
- Age 5-80.
- 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)
- Able to perform and follow simple commands (ex: sit up in bed, lay down in bed)
Show all 9Show fewer
- Pre-Study CT/MRI Imaging stable per PI Sub-I Assessment post ventriculostomy.
- Able to stand
- Able to obtain consent
Who cannot join
- Refractory ICP or needing active ICP management
- Unable to tolerate brief clamping of EVD (<5min)
- Unable to follow simple commands
- Unconscious
- Anticoagulant Therapy
- Known bleeding diathesis
- Scalp Infection
- In the opinion of the Investigator the subject is not a good study candidate
Trial locations and contacts
2 sites in 1 country.
United States2 sites
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 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.
Read the detailed description
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
- Conditions
- Hydrocephalus, Hydrocephalus in Children, Tumor, Brain
- Being tested
- Smart External Drain - SED
- Medical subject headings
- Hydrocephalus, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart External Drain - SEDDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm study | Other | 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). Receives: Device: Smart External Drain - SED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Staff interactions
Average number of staff interactions per patient with standard EVD compared to intervention, the Smart External Drain (SED)
Measured: Two Days
Secondary outcomes (2)
Staff Time
Total minutes spent by staff interacting with standard EVD compared to SED
Measured: Two Days
Safety
Number of Participants with Adverse Events That Are Related to Treatment
Measured: Two Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start12 Apr 2017
- Primary completion15 Aug 2018
- Study completion29 Jan 2019
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
- 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)
- Enrolment
- 56 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
- NCT03113799
- Sponsor's protocol ID
- ASSESSED SED1
- Acronym
- SED
- Status last verified
- Jan 2019
- First submitted
- 20 Mar 2017
- Last updated
- 31 Jan 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 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Performance and Safety of Aqueduct's Smart External Device (SED) Compared to Standard EVD Drains
- ClinicalTrials.gov ID
- NCT03113799
- Acronym / sponsor ID
- SED / ASSESSED SED1
- Conditions
- Hydrocephalus, Hydrocephalus in Children, Tumor, Brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Aqueduct Critical CareIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 29 Jan 2019 (actual)
- First posted
- 14 Apr 2017 (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.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single Arm study | Other | Device: Smart External Drain - SEDSingle 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). |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Stable Neuro - examination on standard EVD assessed as Not Clinically Significant (NCS) by PI or delegated Sub-I prior to study treatment.
- GCS > 13 (minimum of E3V5M5) prior to study treatment.
- 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)
- Age 5-80.
- 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)
Key exclusion criteria (8 listed)
- Refractory ICP or needing active ICP management
- Unable to tolerate brief clamping of EVD (<5min)
- Unable to follow simple commands
- Unconscious
- Anticoagulant Therapy
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 - SEDSubject 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. | Device | Single Arm study |
Primary outcome
Staff interactions
Time frame: Two Days
Average number of staff interactions per patient with standard EVD compared to intervention, the Smart External Drain (SED)
2 secondary outcomes
Staff Time
Time frame: Two Days
Safety
Time frame: Two Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 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
2 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 2 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 9 inclusion and 8 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: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Staff interactions (time frame: Two 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 31 Jan 2019.