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

End Stage Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06056739
• Other study ID #: AM23
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: October 2023
• Source: Alio, Inc.
• Contact: Amy Steig
• Phone: 4158348031
• Email: amy[@]alio.ai
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Device:
• Alio platform
Remote monitoring platform

Locations

Country	Name	City	State
United States	Site 1	Huntley	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Alio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing usage of the Alio platform by the test subject	Assessing compliance and ease of use via surveys	Up to 1 year