Clinical trial · Interventional
A Secondary Study Evaluating Aqueduct's Smart External Drain (SED)
A Secondary Study Evaluating Performance and Safety of Aqueduct's Smart External Drain (SED2)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Device Review performed by Sponsor
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
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 | — |
| Subarachnoid Hemorrhage | — | 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
- EXPERIMENTAL
- label
- Single Arm Study
- description
- 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.
- interventionNames
- Device: Smart External Drain - SED
Primary outcomes (1)
- measure
- The number of subjects which require switching to a standard of care external drain.
- timeFrame
- 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.
- description
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available