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

Not Applicable

Recruiting

• Conditions: End Stage Kidney Disease
• Interventions: Device: Alio platform

• Registration Number: NCT06056739
• Lead Sponsor: Alio, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-21
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-28
• Status Verified: 2023-10
• Study Start: 2023-10-09
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-11
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test Subject	Alio platform	All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Alio platform.

Primary Outcome Measures

Name	Time	Method
Assessing usage of the Alio platform by the test subject	Up to 1 year	Assessing compliance and ease of use via surveys

Trial Locations

Locations (1)

Site 1; 🇺🇸 Huntley, Illinois, United States