A Study to Evaluate the Safety and Effectiveness of Voyager's Access Device for Patients Undergoing Routine Hemodialysis (Access Cannulation Trial II)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dialysis; Complications
- Sponsor
- Voyager Biomedical
- Enrollment
- 100
- Locations
- 8
- Primary Endpoint
- To demonstrate the effectiveness of the study device in facilitating cannulation of arteriovenous fistulas (AVFs) for hemodialysis.
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
To demonstrate the effectiveness of the study device in facilitating cannulation of arteriovenous fistulas (AVFs) for hemodialysis.
Time Frame: 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.
Time Frame: 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 Outcomes
- To investigate time-related parameters surrounding the study device in facilitating hemodialysis.(12 months)
- To further evaluate the safety of the study device(4 weeks from initial implantation)