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Access Cannulation Trial II

NCT05490225 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-10-29

No results posted yet for this 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.

Conditions

  • Dialysis; Complications
  • Vascular Access Complication

Interventions

DEVICE

VenaSure

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.

Sponsors & Collaborators

  • Voyager Biomedical

    lead INDUSTRY

Principal Investigators

  • Stephen Hohmann, MD · Baylor Scott and White Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-23
Primary Completion
2027-03-25
Completion
2027-03-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05490225 on ClinicalTrials.gov