Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM as a Single-Site Vascular Access Device for Hemodialysis Procedures

NCT07599085 — Not applicable, Not yet recruiting, 20 participants, Evolve Medicus, Inc.

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT07599085, acronym ONEPOINT-01
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	20 (Estimated)
Sponsor	Evolve Medicus, Inc. (Industry)
Conditions	Vascular Access
Interventions	OnePoint Dialysis Cannula (Device)
Dates	start 2026-08-01 (estimated), primary completion 2027-08-01 (estimated), completion 2027-08-01 (estimated), first posted 2026-05-20, last updated 2026-05-20

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
OnePoint Dialysis Cannula	Experimental	Device: OnePoint Dialysis Cannula	Single-site vascular access device intended to be used in patients receiving hemodialysis

OnePoint Dialysis Cannula (Device): Single-site vascular access device intended to be used in patients receiving hemodialysis

+Outcome measures

Primary outcomes

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.
Dialysis Cannulation Data CRF [30 days]: Proportion of subjects that, using the device, successfully complete their prescribed number of dialysis treatments over a 30-day period, excluding treatments that fail for other reasons.

+Eligibility

Sex: All, ages: 18 Years to any

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.