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Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters

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. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE December 21, 2015
First Posted Date  ICMJE January 11, 2016
Results First Submitted Date  ICMJE July 16, 2020
Results First Posted Date  ICMJE September 21, 2020
Last Update Posted Date September 21, 2020
Actual Study Start Date  ICMJE April 1, 2016
Actual Primary Completion Date June 4, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 7, 2016)
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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters
Official Title  ICMJE Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Hydrocephaly
Intervention  ICMJE Device: Cerebrospinal Fluid (CSF) Drainage
Placement of Alivio in line flusher during CSF drainage
Other Name: Alivio in line flusher
Study Arms  ICMJE 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
Intervention: Device: Cerebrospinal Fluid (CSF) Drainage
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2020)
4
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2016)
30
Actual Study Completion Date  ICMJE June 14, 2016
Actual Primary Completion Date June 4, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02651337
Other Study ID Numbers  ICMJE P000009795
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alcyone Lifesciences, Inc.
Study Sponsor  ICMJE Alcyone Lifesciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Benjamin Warf, MD Warf, MD Boston Children's Hospital
PRS Account Alcyone Lifesciences, Inc.
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP