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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