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

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ClinicalTrials.gov Identifier: NCT04063787
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
Fist Assist Devices, LLC
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Kidney Diseases Device: Fist Assist Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Use of an Intermittent Pneumatic Compression Device to Promote Vein Dilation in Patients With Kidney Disease to Enable Creation of Arteriovenous Fistulas
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : August 13, 2020
Estimated Study Completion Date : May 13, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fist Assist device (all subjects)

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

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.





Primary Outcome Measures :
  1. Vein diameter [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. AVF creation [ Time Frame: 12 months ]
    Whether or not an arteriovenous fistula was created, as defined by a procedure performed by surgery or interventional radiology connecting an artery to a vein.

  2. AVF maturation [ Time Frame: 12 months ]
    Whether the resultant AVF matured, as defined successful cannulation with two needles for three hemodialysis treatments.

  3. Subsequent exposure to central venous catheters [ Time Frame: 12 months ]
    The subject's subsequent exposure of patients to central venous catheters during their first year for hemodialysis as measured in total number days of central venous catheter access used for hemodialysis.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04063787


Contacts
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Contact: Mary Hammes, MD 773-702-9892 mhammes@medicine.bsd.uchicago.edu
Contact: Rita McGill rmcgill1@medicine.bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Mary Hammes, MD    773-702-9892    mhammes@medicine.bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
Fist Assist Devices, LLC
Investigators
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Principal Investigator: Mary Hammes, MD University of Chicago

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT04063787     History of Changes
Other Study ID Numbers: IRB19-0306
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases