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Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters

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ClinicalTrials.gov Identifier: NCT02651337
Recruitment Status : Completed
First Posted : January 11, 2016
Results First Posted : September 21, 2020
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Alcyone Lifesciences, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hydrocephaly Device: Cerebrospinal Fluid (CSF) Drainage Not Applicable

Detailed Description:

Primary Objective: To collect pressure and flow rate measurements during shunt revision surgeries in human patients.

Pressure recordings of the injected fluid will be obtained using disposable off-the-shelf sterile pressure transducers (which are typically used for intracranial and arterial pressures monitoring) readily available in the operating room. First, the surgeon will attempt to flush the catheter using the Alcyone in-line Flusher device. If this fails, the surgeon may elect to attempt to flush using a standard syringe attached to the catheter. The flow rates will be measured by video, recording the syringe during the flushing maneuver, and then extracting plunger motion information by applying image processing on the acquired videos. In the event the recording equipment is not available (in that these operations are usually unscheduled and sometimes urgent), the same irrigation techniques may be used without the pressure recordings.

Secondary Objective: To analyze the collected data and establish maximal allowable injection pressure and flow rate. The collected data segments for each patient will be analyzed and maximal values for pressure and the saline injection rate will be recorded in a spreadsheet. Inter-patient variation in the results, presumably due to different degrees of occlusion, will be statistically evaluated. We will also determine if any of the catheters which appear occluded in the operating room resume flow with the flushing maneuvers.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : June 4, 2016
Actual Study Completion Date : June 14, 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Drainage with Alivio in-line Flusher
Volume 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
 Device: Cerebrospinal Fluid (CSF) Drainage
Placement of Alivio in line flusher during CSF drainage
Other Name: Alivio in line flusher


Outcome Measures
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Primary Outcome Measures :
  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 . [ Time Frame: Intra-procedural ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must be 30 days to 35 years of age, of any race or gender.
  2. Subjects must be scheduled to undergo a neurosurgical procedure potentially requiring a revision of neurosurgical catheters.
  3. 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:

  1. Inability or unwillingness of subject or parent/guardian to give informed consent/assent.
  2. 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.
  3. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651337


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Alcyone Lifesciences, Inc.
Investigators
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Principal Investigator: Benjamin Warf, MD Warf, MD Boston Children's Hospital
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Alcyone Lifesciences, Inc.
ClinicalTrials.gov Identifier: NCT02651337    
Other Study ID Numbers: P000009795
First Posted: January 11, 2016    Key Record Dates
Results First Posted: September 21, 2020
Last Update Posted: September 21, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases