Vascular Access
Conditions
Brief summary
This is an early feasibility, pre-market, prospective, interventional, single-arm, non-randomized / open-label study intended to support a future pivotal IDE study for eventual FDA clearance of the study device based on the safety and efficacy of the device in cannulating arteriovenous fistulas (AVFs) for hemodialysis procedures.
Interventions
DEVICEOnePoint Dialysis Cannula
Single-site vascular access device intended to be used in patients receiving hemodialysis
Sponsors
Evolve Medicus, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is an adult patient ≥ 18 years of age. 2. Subject with the ability to attend "in-center" hemodialysis. 3. Subject has a requirement of hemodialysis 3 times/week. 4. Subject has an AVF that was determined to be mature by standard clinical definition 5. Subject with ≥ 3 months stable in center hemodialysis with \>90 days use of an AV fistula cannulated with 2 needles with no evidence of stenosis or thrombosis. 6. Subject has an AVF that meets all of the following Rule of 5s: * Flow ≥ 500 mL/min * Diameter ≥ 5 mm * Depth ≤ 5 mm from the skin surface * Length ≥ 5 cm usable for cannulation 7. Subject does not have any established lesions or stents in the access circuit as confirmed by ultrasound. 8. Subject dialyzes at a center that can confirm 30-day data collection on cannulations and is willing to cooperate in performing real-time assessments and record keeping per Sponsor requirements, to assure subject safety requirements.
Exclusion criteria
1. Subject has an existing arteriovenous graft. 2. Subject has any active infection within the past 90 days. 3. Subject is currently receiving or planning home hemodialysis. 4. Subject has a distorted anatomy and/or local vascular injury. 5. Subject has a change in blood thinner regimen in the last 60 days. 6. Subject has any unstable medical or psychiatric conditions likely to impair their ability to participate in the study. 7. Subject has a known history of clinically significant IV drug use. 8. Subject is a pregnant or nursing woman, or anticipates pregnancy in the next 3 months. 9. Subject is enrolled in another study that could confound the results of this study, without documented pre-approval. 10. Subject has a known allergy to plastics. 11. Subject is unwilling to sign the study's consent form. 12. Subject has a life expectancy of less than 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dialysis Cannulation Data CRF | 30 days | Percentage of attempted device cannulations that successfully result in completion of the prescribed hemodialysis treatment sessions over a 30-day period. |
Contacts
CONTACTBritnee Ochabski
Outcome results
None listed