End Stage Kidney Disease
Conditions
Brief summary
The WEAR study is long-term interventional study designed to evaluate patient and clinician use of the Alio platform, per its FDA cleared indications.
Interventions
DEVICEAlio platform
Remote monitoring platform
Sponsors
Alio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age. * Receiving hemodialysis via an AVF or AVG in an arm location at the time of study start. * Able to wear the SmartPatch effectively at the specified location on the arm. * Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures. * Willing and able to wear the SmartPatch as instructed and comply with all interviews, surveys and questionnaires, and schedule of evaluations.
Exclusion criteria
* Skin near the proximity of the AV access that is chronically swollen, infected, inflamed, open wounds, lesions, or has skin eruptions. * Participation in any other clinical trials involving investigational or marketed products that in the opinion of the investigator could affect the quality of the data. * Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessing usage of the Alio platform by the test subject | Up to 1 year | Assessing compliance and ease of use via surveys |
Countries
United States
Contacts
Primary ContactAmy Steig
Backup ContactTala Harake
Outcome results
None listed