Clinical trial NCT05927532: Argyle Safety Fistula Cannula With Anti-reflux Valve Clinical Study
Official title: Argyle Fistula Cannula Pre-market, Prospective, Single Arm, Non-randomized, Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Failure on Dialysis
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2023-07-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the investigation is to confirm the safety and performance of the Argyle™ Safety Fistula Cannula with Anti-reflux Valve for hemodialysis treatment.

Detailed description: The study will be performed at up to 5 US hemodialysis clinics.

Qualified patients who choose to participate and sign informed consent will be enrolled in the study. The investigational sites chosen to participate in this study will be trained on the insertion procedure using plastic fistula cannulas according to established curriculum. A combination of didactic training followed by insertion using a cannulation arm will be conducted. Cannulation on consented subjects will begin after the inserter demonstrates proficiency on the cannulation arm. Proficiency definitions are outlined in the protocol. After two supervised (by Medtronic and/or dedicated, trained super user) successful cannulations on consented subjects, the clinician will be permitted to cannulate without supervision.

Data supporting the primary, secondary, and exploratory objectives will be captured following thirty-six (36) hemodialysis sessions for each enrolled subject.

Cannulations will be performed by a minimum of five different clinicians at up to 5 dialysis clinic sites.

The investigational sites chosen to participate in this study will be trained on the insertion procedure using plastic fistula cannulas for a pre-determined period and according to established curriculum. A combination of didactic training followed by insertion using a cannulation arm will be conducted. After two supervised (by Medtronic and/or dedicated, trained super user) successful cannulations on consented subjects, the clinician will be permitted to cannulate without supervision and the data collection for the primary and secondary objectives will begin. Hemodialysis sessions will be performed, according to the investigator's prescription, throughout the duration of the study. Dialysis adequacy will be verified at baseline and during the mid-week session on weeks 1, 3, 6 and 12. Other than the blood sampling, there are no study-specific procedures, other than cannulation with the Argyle™ Safety Fistula Cannula with Anti-Reflux Valve, that will be required.

Eligibility criteria: Inclusion Criteria:

* Subject who is aged 18 years or older who signed informed consent
* Subject is undergoing in-center hemodialysis
* Subject has an arteriovenous fistulae (AVF) fistula that was determined to be mature by standard clinical definition

Exclusion Criteria:

* Subject is enrolled in another study that could confound the results of this study, without documented pre-approval
* Subject with an existing arteriovenous graft
* Subjects with known allergies to plastics
* Subjects who are unable to read or respond to the questionnaire about satisfaction

Primary outcomes:
measure: Successful Hemodialysis Sessions
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Successful Cannulations
timeFrame: through study completion, an average of 1 year
measure: Cannulation Locations with securement details
timeFrame: through study completion, an average of 1 year
measure: Access-related complications requiring procedural intervention
timeFrame: through study completion, an average of 1 year
measure: Compare prescribed blood flow rates
timeFrame: through study completion, an average of 1 year
measure: Dialysis adequacy
timeFrame: through study completion, an average of 1 year
measure: Cannulator Satisfaction Questionnaire
timeFrame: through study completion, an average of 1 year
measure: Subject Satisfaction Questionnaire
timeFrame: through study completion, an average of 1 year
measure: Impact of delay between training and use of device
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Summary of Needle Stick Injury within past 6 months from start of study by investigational site
timeFrame: in the past 6 months from the start of the study
measure: Time to successful cannulation
timeFrame: During procedure
Locations:
city: Hartford
country: United States
facility: DaVita Hartford
state: Connecticut
city: Columbus
country: United States
facility: DaVita Columbus
state: Georgia
city: Norfolk
country: United States
facility: DaVita Norfolk
state: Virginia
Study officials:
References: