Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM as a Single-Site Vascular Access Device for Hemodialysis Procedures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OnePoint Dialysis Cannula.
- Who it may be relevant to
- Registry conditions: Vascular Access. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device OnePoint Dialysis Cannula
Single-site vascular access device intended to be used in patients receiving hemodialysis
Primary outcome measures
- Dialysis Cannulation Data CRF [Time frame: 30 days]
- Dialysis Cannulation Data CRF [Time frame: 30 days]
Eligibility criteria
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:
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07599085 · ONEPOINT-01