CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 46 enrolled
Drug / intervention
Fist Assistdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04063787
NCT04063787N/ACompleted
CompareCT.gov

Use of an Intermittent Pneumatic Compression Device to Promote Vein Dilation in Patients With Kidney Disease to Enable Creation of Arteriovenous Fistulas

University of Chicago·interventional·Posted Aug 21, 2019·Updated Oct 12, 2023

In Brief

A clinical study evaluating Fist Assist for Kidney Diseases. Completed, enrolled 46 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Diseases
CountriesUnited States
CollaboratorsFist Assist Devices, LLC

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 21, 2019
Enrollment StartMay 13, 2019
Primary CompletionJul 27, 2022
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 6.9 years ago

Interventions

Fist Assistdevice

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.