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NCT05490225 · ClinicalTrials.gov registry record · NA
Access Cannulation Trial II
A NA study of Vascular Access Complication and Dialysis; Complications, sponsored by Voyager Biomedical.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 8
- Study locations
NCT05490225: Recruiting NA study of Vascular Access Complication and Dialysis; Complications, sponsored by Voyager Biomedical.
NCT05490225 is a NA study of Vascular Access Complication and Dialysis; Complications that is actively recruiting participants, run by Voyager Biomedical. The registered enrollment target is 100 participants, below the 739-participant average among 6 other Vascular Access Complication trials with a reported enrollment target (86% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05490225, a NA study of Vascular Access Complication and Dialysis; Complications, is actively recruiting participants, sponsored by Voyager Biomedical.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 8
- Study locations
Study 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.
Primary Outcome
Incidence of success for achieving clinically functional access within a 6-month timeframe from approved cannulation through the study device.
Conditions Studied
Interventions
- DEVICE VenaSure
Study Locations (8)
Texas
- Cardiothoracic and Vascular Surgeons - Austin
- Baylor Scott & White - Dallas
Alabama
- Trinity Research Group - Dothan
California
- Apex Research - Riverside
Massachusetts
- Brigham and Women's Hospital - Boston
New York
- Northwell Health - Hyde Park
South Carolina
- MUSC Health Orangeburg - Orangeburg
Virginia
- Fairlawn Surgery Center - Roanoke
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-04-23 |
| Est. Completion | 2027-03-25 |
| Phase | NA |
What NCT05490225 shows while recruiting
NCT05490225 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 739-participant average among 6 other Vascular Access Complication trials with a reported enrollment target (86% lower).
The record links to 2 conditions, with Vascular Access Complication appearing as the primary indexed condition, and to 1 intervention - of which VenaSure is the first listed.
NCT05490225 lists 8 locations in 7 states (Texas, Alabama, California).
Frequently Asked Questions
What is clinical trial NCT05490225 about?
NCT05490225 is a clinical study titled "Access Cannulation Trial II". 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.
What is the current status of trial NCT05490225?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2025-04-23. Estimated completion is 2027-03-25.
What conditions does trial NCT05490225 study?
This clinical trial studies the following conditions: Vascular Access Complication, Dialysis; Complications.
What interventions are being tested in trial NCT05490225?
The interventions under investigation include: VenaSure (DEVICE).
Who is sponsoring clinical trial NCT05490225?
This trial is sponsored by Voyager Biomedical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05490225 being conducted?
This trial has 8 study locations across Alabama, California, Massachusetts, New York, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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