Ark Device for Vascular Access Complications

(ACT II Trial)

Recruiting at 9 trial locations

Overseen By Supraj Amunje

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: BioTex, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

Stephen Hohmann, MD

Principal Investigator

Baylor Scott and White Health

Eligibility Criteria

This trial is for individuals with difficult-to-access arteriovenous fistulas (AVFs) used for hemodialysis. Candidates must have had multiple failed access attempts, AVFs that are not palpable or too tortuous, and certain measurements of the fistula as determined by ultrasound.

Inclusion Criteria

My dialysis access has failed multiple attempts at needle insertion.

The access surgeon attests that the Ark is likely to be at least equivalent to other methods that could make the AVF easier to access

I have a specific type of access for dialysis in my arm.

Exclusion Criteria

The subject's life expectancy is <1 year per the Investigator

I do not undergo hemodialysis twice a week.

My AVF is made from my own basilic or brachial vein.

Treatment Details

Interventions

• Ark Device (Vascular Access Device)

Trial Overview The Ark device is being tested to see if it's safe and effective for cannulating AVFs in patients undergoing hemodialysis. This single-arm study involves participants who will all receive the Ark intervention at various clinical sites.

Participant Groups

Group I: Ark Implantation Experimental Treatment 1 Intervention

Single arm study. Depending on the clinical needs of the patient, the physician will decide if a single return device is needed (ex. easily cannulatable arterial pull site but the venous return access site is poorly accessible for cannulation) or two devices (both arterial pull and venous return are poorly accessible for cannulation).

Who Is Running the Clinical Trial?

BioTex, Inc.

Lead Sponsor

Trials

10

Recruited

400+

Voyager Biomedical

Lead Sponsor

Trials

1

Recruited

100+