100 Participants Needed

Ark Device for Vascular Access Complications

(ACT II Trial)

Recruiting at 13 trial locations
BL
AU
BL
BC
BO
SA
Overseen BySupraj Amunje
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: BioTex, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is the Ark Device for Vascular Access Complications safe for humans?

The research articles discuss various complications related to vascular access devices, such as infections, bleeding, and thrombosis (blood clots), but do not provide specific safety data for the Ark Device. Therefore, it's unclear if the Ark Device is safe based on the available information.12345

How is the Ark Device treatment different from other treatments for vascular access complications?

The Ark Device is unique because it is designed to improve the reliability of accessing arteriovenous fistulas, which are crucial for hemodialysis, by overcoming technical barriers to using blunt needles. This approach is different from other treatments that may not specifically address the challenges of reliable needle access in mature fistulas.678910

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

SH

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.
See 1 more

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.
See 21 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Healing

The study device is implanted and participants are observed for 6 weeks as the implant site heals

6 weeks

Initial Safety Assessment

Initial safety assessment of the study device is conducted

4 weeks

Treatment and Monitoring

Participants are monitored for 36 months after device implantation as they undergo routine dialysis

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

  • Ark 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
1Treatment groups
Experimental Treatment
Group I: Ark ImplantationExperimental Treatment1 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).

Find a Clinic Near You

Who Is Running the Clinical Trial?

BioTex, Inc.

Lead Sponsor

Trials
10
Recruited
400+

Voyager Biomedical

Lead Sponsor

Trials
1
Recruited
100+

Findings from Research

A review of the MAUDE database revealed 1,118 complications associated with the StarClose SE vascular closure device, with the most common issues being failure to achieve hemostasis (36.6%) and inability to complete the deployment sequence (24.0%).
The types and frequencies of complications reported in the MAUDE database significantly differ from those in clinical trials, suggesting that real-world usage may present additional challenges not captured in controlled studies.
Distribution of reported StarClose SE vascular closure device complications in the manufacturer and user facility device experience database.Johnson, DT., Durack, JC., Fidelman, N., et al.[2013]

References

Analysis of central venous access injuries from claims to the Swedish Patient Insurance Company 2009-2017. [2020]
Identifying vascular access complications among ESRD patients in Europe. A prospective, multicenter study. [2022]
The frequency of vascular complications associated with the use of vascular closure devices varies by indication for cardiac catheterization. [2021]
Factors affecting vascular access complications in children undergoing congenital cardiac catheterization. [2012]
Distribution of reported StarClose SE vascular closure device complications in the manufacturer and user facility device experience database. [2013]
Non-randomized safety and performance evaluation of the av-Guardian vascular access system. [2022]
Second-generation Amplatzer Vascular Plug (AVP) for the treatment of subsequent subclavian backflow type II endoleak after TEVAR. [2022]
Access Site Complications in Thoracic Endovascular Aortic Repair. [2023]
[Anastomotic aneurysm in forearm AV fistula for hemodialysis access--a late complication]. [2019]
Amplatzer&#8482; Vascular Plugs for Embolisation: A 10-Year Single-Centre Retrospective Study. [2023]
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