Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters

• 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: Alcyone Lifesciences, Inc.
• 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

Participant Flow

Recruitment Details	5 participants consented for study participation, 4 patients were enrolled
Pre-assignment Details

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

Baseline Characteristics

Arm/Group Title		Drainage With Alivio In-line Flusher
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
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%

Outcome Measures

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 .
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alivio Ventricular Flusher Device
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%

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.

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Drainage With Alivio In-line Flusher
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%)
Serious Adverse Events
	Drainage With Alivio In-line Flusher
	Affected / at Risk (%)
Total	0/5 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Director of Clinical Operations
• Organization: Alcyone LifeSciences
• Phone: 9787091946
• EMail: jmcguire@alcyonels.com

Publications of Results:

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.

Naradzay JF, Browne BJ, Rolnick MA, Doherty RJ. Cerebral ventricular shunts. J Emerg Med. 1999 Mar-Apr;17(2):311-22. Review.

• 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