Alio WEAR Study: Long-term Wear of the Alio Platform

Alio, Inc.

Status

Enrolling

Conditions

End Stage Kidney Disease

Treatments

Device: Alio platform

Study type

Interventional

Funder types

Industry

Identifiers

NCT06056739

AM23

Details and patient eligibility

About

The WEAR study is long-term interventional study designed to evaluate patient and clinician use of the Alio platform, per its FDA cleared indications.

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.