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

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

Study Overview

• Status: Recruiting
• Conditions: End Stage Kidney Disease
• Intervention / Treatment: Device: Alio platform

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy Steig; Phone Number: 4158348031; Email: amy@alio.ai
• Study Contact Backup: Name: Tala Harake; Phone Number: 9499235884; Email: tala@alio.ai

Study Locations

• United States
  • Illinois
    • Huntley, Illinois, United States, 60142
      • Recruiting
      • Site 1
      • Contact: Stacey Miller; Email: stacey@alio.ai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Subject; All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Alio platform.	Device: Alio platform; Remote monitoring platform
No Intervention: Control Subject; All subjects who are enrolled into the control group and participate in data collection will not receive the noninvasive Alio platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing usage of the Alio platform by the test subject	Assessing compliance and ease of use via surveys	Up to 1 year

Collaborators and Investigators

• Sponsor: Alio, Inc.
• Investigators: Study Director: David Whittaker, MD, Alio

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: AM23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes