End Stage Renal Failure on DialysisNCT05927532
Argyle Safety Fistula Cannula With Anti-reflux Valve Clinical Study
A study testing Argyle Safety Fistula Cannula with Anti-Reflux Valve in people with End Stage Renal Failure on Dialysis, run by Mozarc Medical US LLC at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Failure on Dialysis
- What is being tested?
- Argyle Safety Fistula Cannula with Anti-Reflux Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Mar 2024to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
DaVita Columbus
Columbus, Georgia, 31904
DaVita Hartford
Hartford, Connecticut, 06082
DaVita Norfolk
Norfolk, Virginia, 23505
About this study
Official title: Argyle Fistula Cannula Pre-market, Prospective, Single Arm, Non-randomized, Interventional Study
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.
Read the 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.
- Conditions
- End Stage Renal Failure on Dialysis
- Being tested
- Argyle Safety Fistula Cannula with Anti-Reflux Valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argyle Safety Fistula Cannula with Anti-Reflux ValveDevice
The Argyle Safety Fistula Cannula with Anti-reflux Valve will be used 3x a week for 12 weeks in subjects with an arteriovenous fistulae (AVF) fistula
| Study group | Role | What they receive |
|---|---|---|
| Argyle Fistula Cannula Subjects | Experimental | All subjects enrolled in the study and treated with the Argyle Safety Fistula Cannula with Anti-reflux Valve Receives: Device: Argyle Safety Fistula Cannula with Anti-Reflux Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Hemodialysis Sessions
The primary objective is the percentage of successful hemodialysis sessions using the Argyle™ Safety Fistula Cannula with Anti-reflux Valve.
Measured: through study completion, an average of 1 year
Secondary outcomes (8)
Successful Cannulations
Report the percentage of successful cannulations to achieve successful cannulation in each subject
Measured: through study completion, an average of 1 year
Cannulation Locations with securement details
Characterize cannulation locations and details on the securement of the cannulas after taping during the hemodialysis session by evaluating the staff-reported insertion sites captured on the Dialysis Session case report form
Measured: through study completion, an average of 1 year
Access-related complications requiring procedural intervention
Quantify the number of subjects who had a procedure to correct access-related complications
Measured: through study completion, an average of 1 year
Compare prescribed blood flow rates
Compare prescribed blood flow rates with plastic fistula cannula to average blood flow achieved
Measured: through study completion, an average of 1 year
Dialysis adequacy
Compare baseline dialysis adequacy (e.g., spKt/V and urea reduction ratio (URR) to measure collected at 1, 3, 6 and 12 weeks). The average spKt/V and URR will be compared to measurements reported at basline using steel needles. A repeated measures approach will be utilized to compare baseline to follow-up dialysis adequacy measurements.
Measured: through study completion, an average of 1 year
Cannulator Satisfaction Questionnaire
Assess inserter satisfaction (survey), i.e., ability to access deep fistulas, insertion locations, securement technique, ability to determine proper placement without the usual pulsing flashback seen with traditional needles. Mean satisfaction score (and associated 95% confidence intervals) prior to first use and following final cannulation will be reported.
Measured: through study completion, an average of 1 year
Subject Satisfaction Questionnaire
Characterize subject satisfaction using standardized survey to assess insertion pain
Measured: through study completion, an average of 1 year
Impact of delay between training and use of device
Evaluate any impact of delay between training and use of the subject devices, or time elapsed between cases for each clinician and successful and unsuccessful cannulations. The proportion of successful and unsuccessful cannulations will be predicted with clinician and time between training and cannulation attempt using logistic regression. Statistical significance of the covariate "time between training and cannulation attempt" will be reported.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start10 Mar 2024
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Failure on DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mozarc Medical US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927532
- Sponsor's protocol ID
- MDT19046
- Status last verified
- Mar 2026
- First submitted
- 19 Jan 2023
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Argyle Fistula Cannula Pre-market, Prospective, Single Arm, Non-randomized, Interventional Study
- ClinicalTrials.gov ID
- NCT05927532
- Acronym / sponsor ID
- MDT19046
- Conditions
- End Stage Renal Failure on Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mozarc Medical US LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Argyle Fistula Cannula Subjects | Experimental | Device: Argyle Safety Fistula Cannula with Anti-Reflux ValveAll subjects enrolled in the study and treated with the Argyle Safety Fistula Cannula with Anti-reflux Valve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Argyle Safety Fistula Cannula with Anti-Reflux ValveThe Argyle Safety Fistula Cannula with Anti-reflux Valve will be used 3x a week for 12 weeks in subjects with an arteriovenous fistulae (AVF) fistula | Device | Argyle Fistula Cannula Subjects |
Primary outcome
Successful Hemodialysis Sessions
Time frame: through study completion, an average of 1 year
The primary objective is the percentage of successful hemodialysis sessions using the Argyle™ Safety Fistula Cannula with Anti-reflux Valve.
8 secondary outcomes
Successful Cannulations
Time frame: through study completion, an average of 1 year
Cannulation Locations with securement details
Time frame: through study completion, an average of 1 year
Access-related complications requiring procedural intervention
Time frame: through study completion, an average of 1 year
Compare prescribed blood flow rates
Time frame: through study completion, an average of 1 year
Dialysis adequacy
Time frame: through study completion, an average of 1 year
Cannulator Satisfaction Questionnaire
Time frame: through study completion, an average of 1 year
Subject Satisfaction Questionnaire
Time frame: through study completion, an average of 1 year
Impact of delay between training and use of device
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Argyle Safety Fistula Cannula with Anti-Reflux Valve in people with End Stage Renal Failure on Dialysis, run by Mozarc Medical US LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Hemodialysis Sessions (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.