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NOT YET RECRUITING
NCT07599085
NA
Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM as a Single-Site Vascular Access Device for Hemodialysis Procedures
Sponsor: Evolve Medicus, Inc.
View on ClinicalTrials.gov
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-08-01
Completion Date
2027-08
Last Updated
2026-05-20
Healthy Volunteers
No
Conditions
Interventions
DEVICE
OnePoint Dialysis Cannula
Single-site vascular access device intended to be used in patients receiving hemodialysis