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Tissue Engineering

Decellularized Femoral Artery Transplant for Chronic Kidney Failure (NexeonAVX Trial)

N/A

Recruiting

Research Sponsored by LifeNet Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject requires dialysis access to start or maintain dialysis treatment and placement of an AV access graft is a viable access option

Be male or female, ≥18 years of age at the time of graft placement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

NexeonAVX Trial Summary

This trial tested a new form of artery transplant to see if it was safe and effective.

Who is the study for?

This trial is for men and women over 18 with end-stage renal disease (ESRD) or kidney dysfunction requiring hemodialysis. Participants need dialysis access, must understand the study's demands, provide written consent, and not be in another drug/device study. Those with severe heart issues, recent myocardial infarction, arrhythmias, unstable angina needing treatment, severe vascular disease in arms or unable to follow the visit schedule are excluded.Check my eligibility

What is being tested?

The trial tests a new type of graft called Nexeon AVX Decellularized Femoral Artery for people who require dialysis due to kidney failure. It aims to determine if this graft is safe and effective as a means of accessing the bloodstream for hemodialysis treatments.See study design

What are the potential side effects?

While specific side effects aren't listed here, potential risks may include reactions related to implantation like infection or clotting at the graft site; sensitivity reactions due to processing reagents used in manufacturing; and complications associated with any surgical procedure.

NexeonAVX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need a way to start or keep getting dialysis, and placing a graft for access is possible for me.

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I am 18 years old or older.

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I have severe kidney disease or am on dialysis.

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I can understand the study's requirements and agree to follow them.

NexeonAVX Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

UltraSound evaluation of allograft functional patency.

Secondary outcome measures

Secondary Endpoint

NexeonAVX Trial Design

1Treatment groups

Experimental Treatment

Group I: Open LabelExperimental Treatment1 Intervention

Open Label for subjects with End-Stage Renal Disease

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

LifeNet HealthLead Sponsor

14 Previous Clinical Trials

1,192 Total Patients Enrolled

Media Library

Nexeon AVX Decellularized Femoral Artery (Tissue Engineering) Clinical Trial Eligibility Overview. Trial Name: NCT05880537 — N/A

Kidney Failure Research Study Groups: Open Label

Kidney Failure Clinical Trial 2023: Nexeon AVX Decellularized Femoral Artery Highlights & Side Effects. Trial Name: NCT05880537 — N/A

Nexeon AVX Decellularized Femoral Artery (Tissue Engineering) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05880537 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings available for those who would like to participate in this clinical trial?

"Clinicaltrials.gov confirms that this research project is no longer recruiting participants, as the last update was on May 19th 2023. Although current recruitment for this specific study has concluded, 612 other clinical trials are actively seeking volunteers at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry

2023. "Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05880537.