Status:
COMPLETED
Intermittent Pneumatic Compression Device for Vein Dilation in Kidney Disease Patients to Enable AVF Creation (FACT)
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Fist Assist Devices, LLC
Conditions:
Kidney Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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 sig...
Detailed Description
METHODOLOGY: Intervention: 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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 18 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
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
May 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2022
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04063787
Start Date
May 13 2019
End Date
July 27 2022
Last Update
October 12 2023
Active Locations (1)
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1
University of Chicago Medical Center
Chicago, Illinois, United States, 60637