CompletedNot Applicable

Argyle Safety Fistula Cannula With Anti-reflux Valve Clinical Study

United States40 participantsStarted 2024-03-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Successful Hemodialysis Sessions

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT05927532

SponsorMozarc Medical US LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-15

View on ClinicalTrials.gov More End Stage Renal Failure on Dialysis trials