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

Launched by ALIO, INC. · Sep 21, 2023

Keywords

ClinConnect Summary

The Alio WEAR Study is a clinical trial that aims to understand how well patients and healthcare providers can use the Alio platform for managing end-stage kidney disease. This platform includes a device called the SmartPatch, which is designed to help monitor patients who are receiving hemodialysis. The study is currently looking for participants aged 18 and older who are receiving hemodialysis through a specific type of access point in their arm and can wear the SmartPatch as instructed.

Participants in the study will be asked to wear the SmartPatch and take part in interviews, surveys, and evaluations to help researchers gather important information about the device's use. It’s important to note that people with certain skin conditions near their dialysis access point, or those involved in other clinical trials, may not be eligible to join. This study is a great opportunity for those looking to contribute to research that could improve kidney disease management in the future!

Gender

ALL

Eligibility criteria

• 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.