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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


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

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