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Intermittent Pneumatic Compression Device for Vein Dilation in Kidney Disease Patients to Enable AVF Creation (FACT)

NCT04063787 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-10-12

Study results available
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Summary

This is a single center pilot study that is seeking to determine whether the use of the Fist Assist® device for 360 hours over 90 days by patients with advanced CKD prior to AVF surgery results in significant increases in cephalic vein diameters prior to AVF surgery.

Conditions

Interventions

DEVICE

Fist Assist

The Fist Assist device works by applying pressure to the subject's arm in the area where their arteriovenous fistula will eventually be created. The device is mobile and battery powered. The Fist Assist device will be assigned to each enrolled subject by randomization code. All subjects will be asked to use their assigned device twice daily, for two 2-hour sessions, once in the morning and once in the evening. Patients will apply the device to the non-dominant arm above the level of the elbow, and to keep a written log to record use, complications and any problems. They will be asked to do this for 3 months, and will come in to be evaluated via study visits at Months 3, 6, 9 and 12.

Sponsors & Collaborators

  • Fist Assist Devices, LLC

    collaborator INDUSTRY

  • University of Chicago

    lead OTHER

Principal Investigators

  • Mary Hammes, MD · University of Chicago

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-13
Primary Completion
2022-07-27
Completion
2022-07-27
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04063787 on ClinicalTrials.gov