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Anastomotic Connector

VIG Continued Access Study for Dialysis Access Malfunction (VIG-CAS Trial)

N/A
Waitlist Available
Research Sponsored by Phraxis, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6months
Awards & highlights

VIG-CAS Trial Summary

This trial will allow patients who have been previously enrolled in the VIG study to continue receiving treatment while the marketing application is being prepared and reviewed.

VIG-CAS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cumulative patency
Secondary outcome measures
Acute device success
Interventions required to maintain secondary patency
Number and type of Serious adverse events (SAEs)
+2 more

VIG-CAS Trial Design

1Treatment groups
Experimental Treatment
Group I: VIG Continued AccessExperimental Treatment1 Intervention
Patients referred for AVG implant should be screened for study eligibility. A member of the Research Team will evaluate the patient for eligibility. If all initial inclusion criteria are met and no exclusion criteria are present, a member of the Research Team should inform the patient about the study's purpose and should obtain written informed consent. Final enrollment eligibility is determined at the time of surgery, after the physician has confirmed the final inclusion criterion is met. Enrolled subjects will be assigned a unique study subject identification number.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VIG Continued Access Study
2022
N/A
~20

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Who is running the clinical trial?

Phraxis, Inc.Lead Sponsor
1 Previous Clinical Trials
158 Total Patients Enrolled
Cindy Setum, PhDStudy DirectorVP of Clinical Affairs

Frequently Asked Questions

~4 spots leftby Apr 2025