VIG Continued Access Study for Dialysis Access Malfunction

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Trinity Research Group, LLC, Dothan, AL
Dialysis Access Malfunction
VIG Continued Access Study - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The continued access study of the VIG (hereafter referred to as the 'Venous InterGraft Continued Access Study, or 'VIG-CAS') allows for continued enrollment of subjects while the marketing application is being prepared and subsequently reviewed by FDA. The VIG-CAS will include the same patient population, follow-up schedule, and study endpoints as the VIG-only study.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Dialysis Access Malfunction

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 6months

6 months
Cumulative patency
Interventions required to maintain secondary patency
Primary Unassisted Patency
Time to First Cannulation
6months
Number and type of Serious adverse events (SAEs)
At implant
Acute device success

Trial Safety

Safety Progress

1 of 3

Other trials for Dialysis Access Malfunction

Trial Design

1 Treatment Group

VIG Continued Access
1 of 1
Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: VIG Continued Access Study · No Placebo Group · N/A

VIG Continued Access
Device
Experimental Group · 1 Intervention: VIG Continued Access Study · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6months
Closest Location: Trinity Research Group, LLC · Dothan, AL
Photo of alabama 1Photo of alabama 2Photo of alabama 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Dialysis Access Malfunction
0 CompletedClinical Trials

Who is running the clinical trial?

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

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a diagnosis of End Stage Renal Disease.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.