N/A
N=5
Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters
Hydrocephaly
Bottom Line
View on ClinicalTrials.gov: NCT02651337 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: To Demonstrate That the Flusher Can be Primed, Connected, and Activated in a Sterile Clinical Setting Per the Instructions for Use by the Treating Investigator . — 4; 4; 4; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cerebrospinal Fluid (CSF) Drainage (Device)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Alcyone Therapeutics, Inc
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Demonstrate That the Flusher Can be Primed, Connected, and Activated in a Sterile Clinical Setting Per the Instructions for Use by the Treating Investigator . |
4; 4; 4; 4; 3 | — |
Summary
The objective of this pilot study is to perform a set of pressure and flow rate measurements in order to quantitatively characterize safe irrigation or "flushing" of a ventricular shunt catheter, a routine maneuver performed by a neurosurgeon during a shunt revision surgery. This maneuver involves injecting saline with a syringe to clear plugged shunt catheters. Based on data obtained in Stage I of the study, a device has been fabricated which provides the same small-volume pulse of fluid used by surgeons. In Stage II of the study, pressure and flow rate measurements generated by this specialized flusher device will be collected and measured.
Eligibility Criteria
Inclusion Criteria
- Subjects must be 30 days to 35 years of age, of any race or gender.
- Subjects must be scheduled to undergo a neurosurgical procedure potentially requiring a revision of neurosurgical catheters.
- Subjects aged >18 years of age must be willing and able to provide written informed consent. Parental consent will be required for minors.
Exclusion Criteria
- Inability or unwillingness of subject or parent/guardian to give informed consent/assent.
- Judgment of the investigator, surgeon, or any member of the care team (including anesthesiology or operating room nursing staff) that participation in the study will interfere with, or be detrimental to, administration of optimal healthcare of the subject.
- Inability or unwillingness of subject to endure the test or any other condition that would preclude or bias the results of the study according to the judgment of the investigator.
Data sourced from ClinicalTrials.gov (NCT02651337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.