Clinical trial · Interventional
A Study Evaluate Aqueduct's Smart External Drain
A Study to Evaluate the Performance and Safety of Aqueduct's Smart External Device (SED) Compared to Standard EVD Drains
NCT03113799CI-TRIAL-00036863SEDcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hydrocephalus | — | UNRESOLVED | — |
| Hydrocephalus in Children | — | UNRESOLVED | — |
| Tumor, Brain | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Smart External Drain - SED | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single Arm study
- description
- 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).
- interventionNames
- Device: Smart External Drain - SED
Primary outcomes (1)
- measure
- Staff interactions
- timeFrame
- Two Days
- description
- Average number of staff interactions per patient with standard EVD compared to intervention, the Smart External Drain (SED)
Secondary outcomes (2)
- measure
- Staff Time
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Stable Neuro - examination on standard EVD assessed as Not Clinically Significant (NCS) by PI or delegated Sub-I prior to study treatment. 2. GCS \> 13 (minimum of E3V5M5) prior to study treatment. 3. 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) 4. Age 5-80. 5. 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) 6. Able to perform and follow simple commands (ex: sit up in bed, lay down in bed) 7. Pre-Study CT/MRI Imaging stable per PI Sub-I Assessment post ventriculostomy. 8. Able to stand 9. Able to obtain consent Exclusion Criteria: 1. Refractory ICP or needing active ICP management 2. Unable to tolerate brief clamping of EVD (\<5min) 3. Unable to follow simple commands 4. Unconscious 5. Anticoagulant Therapy 6. Known bleeding diathesis 7. Scalp Infection 8. In the opinion of the Investigator the subject is not a good study candidate
References
Publications (0)
Data not yet available
No reference posted for this study.