Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM… (NCT07599085) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM as a Single-Site Vascular Access Device for Hemodialysis Procedures
20 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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.
Exclusion criteria
. Subject has an existing arteriovenous graft.
. Subject has any active infection within the past 90 days.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.