End Stage Renal Failure on Dialysis Clinical Trial
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | October 15, 2024 |
Est. primary completion date | October 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | DaVita Columbus | Columbus | Georgia |
United States | DaVita Hartford | Hartford | Connecticut |
United States | DaVita Norfolk | Norfolk | Virginia |
United States | DaVita Spartanburg | Spartanburg | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medtronic - MITG |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Summary of Needle Stick Injury within past 6 months from start of study by investigational site | Summarize any reported needle stick injury reports in the past 6 months from the start of the study, as permitted by the investigational site | in the past 6 months from the start of the study | |
Other | Time to successful cannulation | Report the time required to achieve successful cannulation | During procedure | |
Primary | Successful Hemodialysis Sessions | The primary objective is the percentage of successful hemodialysis sessions using the Argyle™ Safety Fistula Cannula with Anti-reflux Valve. | through study completion, an average of 1 year | |
Secondary | Successful Cannulations | Report the percentage of successful cannulations to achieve successful cannulation in each subject | through study completion, an average of 1 year | |
Secondary | 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 | through study completion, an average of 1 year | |
Secondary | Access-related complications requiring procedural intervention | Quantify the number of subjects who had a procedure to correct access-related complications | through study completion, an average of 1 year | |
Secondary | Compare prescribed blood flow rates | Compare prescribed blood flow rates with plastic fistula cannula to average blood flow achieved | through study completion, an average of 1 year | |
Secondary | 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. | through study completion, an average of 1 year | |
Secondary | 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. | through study completion, an average of 1 year | |
Secondary | Subject Satisfaction Questionnaire | Characterize subject satisfaction using standardized survey to assess insertion pain | through study completion, an average of 1 year | |
Secondary | 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. | through study completion, an average of 1 year |
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