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SelfWrap for Chronic Kidney Disease (SAVE-FistulaS Trial)

N/A

Recruiting

Research Sponsored by VenoStent

Eligibility Criteria Checklist

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

Must have

Age of at least 18 years

Referred for creation of a new AVF

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at up to 6 months

Awards & highlights

SAVE-FistulaS Trial Summary

This trial studies a new wrap to improve safety & effectiveness of fistula creation for CKD patients.

Who is the study for?

This trial is for adults over 18 with chronic kidney disease who need a new arteriovenous fistula (AVF) for hemodialysis. Participants must be able to follow the study plan and attend check-ups for 3 years.Check my eligibility

What is being tested?

The study compares the safety and effectiveness of a new bioabsorbable wrap called SelfWrap applied around an AVF, versus standard care without this wrap in patients undergoing AVF creation.See study design

What are the potential side effects?

Potential side effects may include local reactions at the site where the AVF is created, such as infection, pain, or inflammation due to the SelfWrap material.

SAVE-FistulaS Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

I am referred for a new arteriovenous fistula creation.

SAVE-FistulaS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at up to 6 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

Freedom from access-related adverse events through 30 days

Unassisted Maturation by 180 days

SAVE-FistulaS Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment ArmExperimental Treatment1 Intervention

Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery

Group II: Control ArmPlacebo Group1 Intervention

AVF creation surgery without any intervention (untreated AVF control, or standard of care)

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

VenoStentLead Sponsor

1 Previous Clinical Trials

20 Total Patients Enrolled

1 Trials studying Catheter Dysfunction

20 Patients Enrolled for Catheter Dysfunction

Timothy Boire, PhDStudy DirectorVenoStent, Inc.

Frequently Asked Questions

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

How many participants have enrolled in this clinical experiment?

"Indeed, the information on clinicaltrials.gov confirms that this trial is still in recruitment mode. The study was first made available to participants on November 1st 2023 and has since been updated for a final time on November 21st 2023. Currently 200 individuals are sought from two locations."

Answered by AI

Is it still feasible to enroll for this research trial?

"Indeed, according to clinicaltrials.gov, this medical study is still open for recruitment. Originally posted on November 1st 2021 and last updated November 21st 2021, the trial requires 200 participants from two sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

2023. "SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06001827.

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