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

Last updated: October 9, 2023
Sponsor: Alio, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Alio platform

Clinical Study ID

NCT06056739
AM23
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 18 years of age.
  • Receiving hemodialysis via an AVF or AVG in an arm location at the time of studystart.
  • 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 obtainedprior 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

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 marketedproducts 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 riskto the subject and/or compromise the quality of the clinical trial.

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Alio platform
Phase:
Study Start date:
October 09, 2023
Estimated Completion Date:
April 01, 2024

Connect with a study center

  • Site 1

    Huntley, Illinois 60142
    United States

    Active - Recruiting

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