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Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters

This study is currently recruiting participants.
Verified July 2017 by Alcyone Lifesciences, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02651337
First Posted: January 11, 2016
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcyone Lifesciences, Inc.
  Purpose
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 Intervention Phase
Hydrocephaly Device: Cerebrospinal Fluid (CSF) Drainage Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters

Resource links provided by NLM:


Further study details as provided by Alcyone Lifesciences, Inc.:

Primary Outcome Measures:
  • Characterization of safe shunt catheter "flushing" using a quantitative assessment of saline injection volume (mls) required to flush the CSF shunt using the Alivio in-line Flusher. [ Time Frame: Intra-procedural ]
    Quantitative assessment of saline injection volume (mls) required to flush the CSF shunt using the Alivio in-line Flusher


Estimated Enrollment: 30
Actual Study Start Date: March 2016
Estimated Study Completion Date: February 28, 2018
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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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
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


Contacts
Contact: Tomer Anor, PhD 617-355-0151 Tomer.Anor@childrens.harvard.edu
Contact: Benjamin Warf, MD 617-355-4932 Benjamin.Ward@childrens.harvard.edu

Locations
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Benjamin Warf, MD    617-355-4932    Benjamin.Warf@childrens.harvard.edu   
Contact: Joseph Madsen, MD    616-355-6005    Joseph.Madsen@childrens.harvard.edu   
Sponsors and Collaborators
Alcyone Lifesciences, Inc.
Investigators
Principal Investigator: Benjamin Warf, MD Warf, MD Boston Children’s Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Alcyone Lifesciences, Inc.
ClinicalTrials.gov Identifier: NCT02651337     History of Changes
Other Study ID Numbers: P000009795
First Submitted: December 21, 2015
First Posted: January 11, 2016
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases