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

NCT04063787 | Completed Results FDA Device

• 1 other identifier: IRB19-0306
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Vein Diameter

  The primary outcome will be the difference in the vein diameter measured in millimeters with use of a vascular ultrasound device before and after Fist Assist use. The standard deviation of the change in vein diameter will be approximately 0.75mm.

  3 months

Secondary Outcomes (3)

• AVF Creation

  12 months

• AVF Maturation

  12 months

• Subsequent Exposure to Central Venous Catheters

  12 months

Study Arms (1)

Fist Assist device (all subjects)

EXPERIMENTAL

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.

Device: Fist Assist

Interventions

Fist Assist DEVICE

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.

Fist Assist device (all subjects)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• and older
• Followed in the University of Chicago Medical Center's Nephrology Clinic
• Expected to initiate hemodialysis
• Estimated Glomerular Filtration Rate (eGFR) \<30 mL/min.1.73m

You may not qualify if:

• Refusal/inability to give informed consent
• Inability to comply with trial requirements,
• Arm infections and/or skin disorders that require frequent medical attention.
• Patients with obvious scarring from IV drug use
• Previous phlebitis.
• Previous occluded arteriovenous grafts or fistulae
• Arterial aneurysms
• Arm deep vein thrombosis
• Any previous vascular surgery on the non-dominant arm.
• Limited cognitive ability
• Motor or sensory deficits in the upper arm
• Upon preliminary evaluation of the cephalic vein (measured 5 cm proximal to the styloid process of the radius, and at the antecubital fossa) there are no detectable superficial veins of at least 1.0 mm diameter, or superficial vein of more than 3.0 mm is present in this lower arm location.

Sponsors & Collaborators

• University of Chicago: lead
• Fist Assist Devices, LLC: collaborator

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Mary Hammes
• Organization: University of Chicago

mhammes@bsd.uchicago.edu

773-702-6134

Study Officials

• Mary Hammes, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 21, 2019
• Study Start: May 13, 2019
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: October 12, 2023
• Results First Posted: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)