Access Cannulation Trial II

Not Applicable

Recruiting

• Conditions: Dialysis; Complications; Vascular Access Complication
• Interventions: Device: Ark Implantation

• Registration Number: NCT05490225
• Lead Sponsor: Voyager Biomedical

Brief Summary

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.

Detailed 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 study 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 Timeline

• Study First Submitted: 2022-08-04
• Study First Submitted QC: 2022-08-04
• Study First Posted: 2022-08-05
• Study Start: 2025-04-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-23
• Primary Completion: 2027-03-25
• Study Completion: 2027-03-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
To demonstrate the effectiveness of the study device in facilitating cannulation of arteriovenous fistulas (AVFs) for hemodialysis.	6 months	Incidence of success for achieving clinically functional access within a 6-month timeframe from approved cannulation through the study device.
To evaluate the safety of the study device.	12 months	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)

Secondary Outcome Measures

Name	Time	Method
To investigate time-related parameters surrounding the study device in facilitating hemodialysis.	12 months	Cumulative duration (days) of hemodialysis catheter exposure (post device implantation), including CVC reinsertion events
To further evaluate the safety of the study device	4 weeks from initial implantation	Initial Safety Assessment (Time Frame = 4 weeks from initial implantation) adjudicated by a Data Monitoring Committee (DMC).

Trial Locations

Locations (11)

Private Practice; 🇺🇸 Dothan, Alabama, United States

Harvard Medical School; 🇺🇸 Boston, Massachusetts, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

Columbia University; 🇺🇸 New York, New York, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Balor Scott & White; 🇺🇸 Dallas, Texas, United States

Star Vascular; 🇺🇸 San Antonio, Texas, United States

MUSC Health Orangeburg; 🇺🇸 Orangeburg, South Carolina, United States

Trinity Research Group; 🇺🇸 Dothan, Alabama, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Fairlawn Surgery Center; 🇺🇸 Roanoke, Virginia, United States