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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.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Hydrocephaly
Intervention Device: Cerebrospinal Fluid (CSF) Drainage
Enrollment 4
Recruitment Details 5 participants consented for study participation, 4 patients were enrolled
Pre-assignment Details  
Arm/Group Title Drainage With Alivio In-line Flusher
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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

Cerebrospinal Fluid (CSF) Drainage: Placement of Alivio in line flusher during CSF drainage

Period Title: Overall Study
Started 5
Completed 4
Not Completed 1
Arm/Group Title Drainage With Alivio In-line Flusher
Hide Arm/Group Description

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

Cerebrospinal Fluid (CSF) Drainage: Placement of Alivio in line flusher during CSF drainage

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
Consent was received by five (5) subjects, whom completed baseline assessments; only four (4) subjects participated in the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
3
  60.0%
Between 18 and 65 years
2
  40.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants
15
(1 to 27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
5
 100.0%
Male
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
 100.0%
1.Primary Outcome
Title 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 .
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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.

Time Frame Intra-procedural
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alivio Ventricular Flusher Device
Hide Arm/Group Description:
The Alivio Ventricular Flusher Device (Flusher) is used in the treatment of patients with hydrocephalus. It is an accessory component that may be connected to a shunt system, which is designed to aid in resuming flow in a non-flowing ventricular catheter.
Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
Ability to Prime the Flusher
4
 100.0%
Adequate Flusher Connection to Shunt
4
 100.0%
System Flushed by dome compression
4
 100.0%
Dome able to be Refilled
4
 100.0%
Dome able to be Evacuated
3
  75.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alivio Ventricular Flusher Device
Comments [Not Specified]
Type of Statistical Test Other
Comments It is a one arm clinical study. No comparison between groups was made.
Other Statistical Analysis The study tested the hypothesis that the Alivio flusher could increase flow in occluded or sluggish flowing catheters. Analysis was made on the basis of the procedural results related to priming the flusher, connecting the flusher to the shunt, flushing the system by dome compression, the ability to refill the dome, and the ability to evacuate the dome.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Drainage With Alivio In-line Flusher
Hide Arm/Group Description

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

Cerebrospinal Fluid (CSF) Drainage: Placement of Alivio in line flusher during CSF drainage

All-Cause Mortality
Drainage With Alivio In-line Flusher
Affected / at Risk (%)
Total   0/5 (0.00%) 
Hide Serious Adverse Events
Drainage With Alivio In-line Flusher
Affected / at Risk (%)
Total   0/5 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Drainage With Alivio In-line Flusher
Affected / at Risk (%)
Total   0/5 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Operations
Organization: Alcyone LifeSciences
Phone: 9787091946
EMail: jmcguire@alcyonels.com
Layout table for additonal information
Responsible Party: Alcyone Lifesciences, Inc.
ClinicalTrials.gov Identifier: NCT02651337    
Other Study ID Numbers: P000009795
First Submitted: December 21, 2015
First Posted: January 11, 2016
Results First Submitted: July 16, 2020
Results First Posted: September 21, 2020
Last Update Posted: September 21, 2020