A Study Evaluate Aqueduct's Smart External Drain (NCT03113799) | Clinical Trial Compass
CompletedNot Applicable
A Study Evaluate Aqueduct's Smart External Drain
United States56 participantsStarted 2017-04-12
Plain-language 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.
Who can participate
Age range
5 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.