Status: Not yet recruiting
Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM as a Single-Site Vascular Access Device for Hemodialysis Procedures
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.
Participants needed: 20
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Evolve Medicus, Inc.Updated: May 20, 2026
Eligibility criteria
Subject is an adult patient ≥ 18 years of age. [+10]
Subject has an existing arteriovenous graft. [+11]