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 Yet Recruiting DMC

• 1 other identifier: ONEPOINT-01
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vascular Access

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

OnePoint Dialysis Cannula

EXPERIMENTAL

Single-site vascular access device intended to be used in patients receiving hemodialysis

Device: OnePoint Dialysis Cannula

Interventions

OnePoint Dialysis Cannula DEVICE

Single-site vascular access device intended to be used in patients receiving hemodialysis

OnePoint Dialysis Cannula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is an adult patient ≥ 18 years of age.
• Subject with the ability to attend "in-center" hemodialysis.
• Subject has a requirement of hemodialysis 3 times/week.
• Subject has an AVF that was determined to be mature by standard clinical definition
• 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.
• 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
• Subject does not have any established lesions or stents in the access circuit as confirmed by ultrasound.
• 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.

You may not qualify if:

• Subject has an existing arteriovenous graft.
• Subject has any active infection within the past 90 days.
• Subject is currently receiving or planning home hemodialysis.
• Subject has a distorted anatomy and/or local vascular injury.
• Subject has a change in blood thinner regimen in the last 60 days.
• Subject has any unstable medical or psychiatric conditions likely to impair their ability to participate in the study.
• Subject has a known history of clinically significant IV drug use.
• Subject is a pregnant or nursing woman, or anticipates pregnancy in the next 3 months.
• Subject is enrolled in another study that could confound the results of this study, without documented pre-approval.
• Subject has a known allergy to plastics.
• Subject is unwilling to sign the study's consent form.
• Subject has a life expectancy of less than 12 months.

Sponsors & Collaborators

• Evolve Medicus, Inc.: lead

Central Study Contacts

Britnee Ochabski

CONTACT

19493224050; OchabskiConsulting@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share