Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM as a Single-Site Vascular Access Device for Hemodialysis Procedures (ONEPOINT-01)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vascular Access
• Intervention / Treatment: Device: OnePoint Dialysis Cannula

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Britnee Ochabski; Phone Number: 19493224050; Email: OchabskiConsulting@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OnePoint Dialysis Cannula; Single-site vascular access device intended to be used in patients receiving hemodialysis	Device: OnePoint Dialysis Cannula; Single-site vascular access device intended to be used in patients receiving hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dialysis Cannulation Data CRF	Percentage of attempted device cannulations that successfully result in completion of the prescribed hemodialysis treatment sessions over a 30-day period.	30 days
Dialysis Cannulation Data CRF	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.	30 days

Collaborators and Investigators

• Sponsor: Evolve Medicus, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ONEPOINT-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No