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
|Condition or disease||Intervention/treatment||Phase|
|Kidney Diseases||Device: Fist Assist||Not Applicable|
Show Detailed Description
|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|
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.
- 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.
- 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.
- AVF maturation [ Time Frame: 12 months ]Whether the resultant AVF matured, as defined successful cannulation with two needles for three hemodialysis treatments.
- 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.
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
|Contact: Mary Hammes, MDfirstname.lastname@example.org|
|Contact: Rita McGillemail@example.com|
|United States, Illinois|
|University of Chicago Medical Center||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Mary Hammes, MD 773-702-9892 firstname.lastname@example.org|
|Principal Investigator:||Mary Hammes, MD||University of Chicago|