Health TrialsbyHealthPanel

Access Cannulation Trial II

ConditionsDialysis; ComplicationsVascular Access Complication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVoyager Biomedical

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Arterial/Pull Zone: _____ mm deep

Venous/Push Zone: _____ mm deep

Failed access attempt in a fistula that was previously approved for cannulation, or

Unable to palpate the fistula such that cannulation is not possible without patient risk.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • VenaSure

    Device

    The device will be surgically implanted at the access site in subjects undergoing routine hemodialysis. The device is expected to provide a target to aid in long-term cannulation success.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Ark ImplantationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To demonstrate the effectiveness of the study device in facilitating cannulation of arteriovenous fistulas (AVFs) for hemodialysis.

Incidence of success for achieving clinically functional access within a 6-month timeframe from approved cannulation through the study device.

Time frame
6 months
2

To evaluate the safety of the study device.

The assessment and occurrence of device-related, serious adverse events (SAEs) of clinical interest (infection, aneurysm, complicated seroma) during a 12- month follow-up period from initial implantation adjudicated by a Data Monitoring Committee (DMC)

Time frame
12 months

Secondary outcomes

1

To investigate time-related parameters surrounding the study device in facilitating hemodialysis.

Cumulative duration (days) of hemodialysis catheter exposure (post device implantation), including CVC reinsertion events

Time frame
12 months
2

To further evaluate the safety of the study device

Incidence and types of device-related complications

Time frame
12 months
3

To further evaluate the safety of the study device

Days to successful cannulation and hemodialysis through the device

Time frame
12 months
4

To further evaluate the safety of the study device

Vascular access interventions required to achieve the primary effectiveness endpoint

Time frame
6mo from approved cannulation through the device

Other outcomes

1

Exploratory Outcome 1

Infiltration rate and AVF failure rate after infiltration

Time frame
36 months
2

Exploratory Outcome 2

Patient Satisfaction Survey

Time frame
SCRN/BSLN, 6 months, 12 months
3

Exploratory Outcome 3

Utilization of health care resources: health economic data analysis to be performed based on available study data for the treatment related costs (e.g. procedural costs, hospital costs, etc.)

Time frame
12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Voyager Biomedical

Lead sponsor

Source ClinicalTrials.gov
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