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

Description

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

Conditions

End Stage Kidney Disease

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Study Overview

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Study Details

Study overview

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

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

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

Condition
End Stage Kidney Disease
Intervention / Treatment

-

Contacts and Locations

Huntley

Site 1, Huntley, Illinois, United States, 60142

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alio, Inc.,

David Whittaker, MD, STUDY_DIRECTOR, Alio

Study Record Dates

2024-04-01