Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters
1 other identifier
interventional
4
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2015
CompletedFirst Posted
Study publicly available on registry
January 11, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2016
CompletedResults Posted
Study results publicly available
September 21, 2020
CompletedSeptember 21, 2020
August 1, 2020
2 months
December 21, 2015
July 16, 2020
September 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 .
Criteria for success: Investigator Determination if the Flusher can be properly primed. Investigator Determination if the Flusher can be easily connected to current shunt components. Investigator Determination if the Flusher can be activated. The following scenarios were also assessed: A noticeable resistance to compression/collapse of the dome to indicate that the Ventricular Catheter is too tightly blocked to be flushed. If the dome does not refill the Ventricular Catheter may still be non-flowing. If the dome refills, the flushing procedure may be repeated as needed and/or as determined reasonable by the surgeon.
Intra-procedural
Study Arms (1)
Drainage with Alivio in-line Flusher
EXPERIMENTALVolume of saline needed to drain CSF using the Alivio in-line Flusher historically compared with volume of saline needed to drain CSF using a standard syringe
Interventions
Placement of Alivio in line flusher during CSF drainage
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (2)
Boop FA, Medhkour A, Honeycutt J, James C, Cherny WB, Duntsch C. In vitro testing of current spread during ventricular catheter coagulation using diathermy. Technical note. J Neurosurg. 2007 Feb;106(2 Suppl):165-8. doi: 10.3171/ped.2007.106.2.165.
PMID: 17330548RESULTNaradzay JF, Browne BJ, Rolnick MA, Doherty RJ. Cerebral ventricular shunts. J Emerg Med. 1999 Mar-Apr;17(2):311-22. doi: 10.1016/s0736-4679(98)00168-1.
PMID: 10195493RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Operations
- Organization
- Alcyone LifeSciences
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin Warf, MD Warf, MD
Boston Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2015
First Posted
January 11, 2016
Study Start
April 1, 2016
Primary Completion
June 4, 2016
Study Completion
June 14, 2016
Last Updated
September 21, 2020
Results First Posted
September 21, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share