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

Status unconfirmed · Not applicable

Conditions studied: End Stage Kidney Disease

In brief

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

Key facts

Study ID

NCT06056739

Run by

Alio, Inc.

People needed

250

Starts

2023-10-09

Expected to finish

2024-04-01

Last updated by the study team

2023-10-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Site 1 — Huntley, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.