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Procedure

Fist Assist for Kidney Disease (FACT Trial)

N/A
Waitlist Available
Led By Mary Hammes, MD
Research Sponsored by University of Chicago
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 12 months
Awards & highlights

FACT Trial Summary

This trial is testing whether a device that assists in making veins larger can help patients with advanced CKD before surgery to create a new vein for dialysis.

FACT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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
Vein Diameter
Secondary outcome measures
AVF Creation
AVF Maturation
Subsequent Exposure to Central Venous Catheters

FACT Trial Design

1Treatment groups
Experimental Treatment
Group I: Fist Assist device (all subjects)Experimental Treatment1 Intervention
All study subjects will have Stage 4 or 5 Chronic Kidney Disease (CKD) that requires them to start hemodialysis. In preparation for hemodialysis, they will have an arteriovenous fistula (AVF) procedure which provides access to the veins for dialysis. This study is testing a device called the Fist Assist to dilate the vein in preparation for dialysis. The device is similar to a blood pressure cuff (worn around the arm and applies pressure). All study participants will wear the Fist Assist twice a day up to three months before their AVF procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fist Assist
2019
N/A
~50

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,000 Previous Clinical Trials
817,584 Total Patients Enrolled
Fist Assist Devices, LLCUNKNOWN
Mary Hammes, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
1,520 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Intermittent Pneumatic Compression Device for Vein Dilation in Kidney Disease Patients to Enable AVF Creation (FACT)
2019. "Intermittent Pneumatic Compression Device for Vein Dilation in Kidney Disease Patients to Enable AVF Creation (FACT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04063787.
~8 spots leftby Apr 2025
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