Vascular AccessONEPOINT-01NCT07599085
Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM as a Single-Site Vascular Access Device for Hemodialysis Procedures
A study testing OnePoint Dialysis Cannula in people with Vascular Access, run by Evolve Medicus, Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access
- What is being tested?
- OnePoint Dialysis Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- OnePoint Dialysis Cannula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnePoint Dialysis CannulaDevice
Single-site vascular access device intended to be used in patients receiving hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| OnePoint Dialysis Cannula | Experimental | Single-site vascular access device intended to be used in patients receiving hemodialysis Receives: Device: OnePoint Dialysis Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Aug 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular AccessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evolve Medicus, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599085
- Sponsor's protocol ID
- ONEPOINT-01
- Acronym
- ONEPOINT-01
- Status last verified
- May 2026
- First submitted
- 17 Apr 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM as a Single-Site Vascular Access Device for Hemodialysis Procedures
- ClinicalTrials.gov ID
- NCT07599085
- Acronym / sponsor ID
- ONEPOINT-01 / ONEPOINT-01
- Conditions
- Vascular Access
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Evolve Medicus, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OnePoint Dialysis Cannula | Experimental | Device: OnePoint Dialysis CannulaSingle-site vascular access device intended to be used in patients receiving hemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnePoint Dialysis CannulaSingle-site vascular access device intended to be used in patients receiving hemodialysis | Device | OnePoint Dialysis Cannula |
Primary outcome
Dialysis Cannulation Data CRF
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing OnePoint Dialysis Cannula in people with Vascular Access, run by Evolve Medicus, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Britnee Ochabski (19493224050, OchabskiConsulting@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dialysis Cannulation Data CRF (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.