Trial Outcomes & Findings for Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters (NCT NCT02651337)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

Intra-procedural

Results posted on

2020-09-21

Participant Flow

5 participants consented for study participation, 4 patients were enrolled

Participant milestones

Participant milestones
Measure	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 Cerebrospinal Fluid (CSF) Drainage: Placement of Alivio in line flusher during CSF drainage
Overall Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Drainage With Alivio In-line Flusher n=5 Participants 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
Age, Categorical <=18 years	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	15 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Alivio Ventricular Flusher Device n=4 Participants 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.
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 . Adequate Flusher Connection to Shunt	4 Participants
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 . System Flushed by dome compression	4 Participants
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 . Dome able to be Refilled	4 Participants
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 . Dome able to be Evacuated	3 Participants
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 . Ability to Prime the Flusher	4 Participants

Adverse Events

Drainage With Alivio In-line Flusher

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Operations

Alcyone LifeSciences

Phone: 9787091946

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place