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Ark Cannulation Trial II — ACT II  

Vascular Access Complication Clinical Trial

Official title:
A Study to Evaluate the Safety and Effectiveness of the Voyager Ark for Patients Undergoing Routine Hemodialysis (Ark Cannulation Trial II)

Clinical Trial Summary

This is a pivotal, interventional, prospective, single-arm, open-label, multi-site clinical investigation intended to support FDA clearance of the Ark based on the safety and efficacy of the device in cannulating arteriovenous fistulas (AVFs) for hemodialysis procedures.

Clinical Trial Description

This clinical investigation is estimated to last approximately 48-60 months, from initial participant enrollment until all data collection is complete on the final participant. After the patient has the Ark device implanted, they will be observed for 6 weeks as the implant site heals. The patient will be monitored for 36 months after device implantation as they undergo routine dialysis. Subjects will exit the investigation after the last visit and no device-related adverse events have been identified or are being monitored ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05490225
Study type Interventional
Source BioTex, Inc.
Contact Britnee L Ochabski
Phone 713-741-0111
Email britnee.ochabski@biotexmedical.com
Status Not yet recruiting
Phase N/A
Start date July 1, 2024
Completion date November 1, 2028
View Details
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