Last updated: October 9, 2023
Sponsor: Alio, Inc.
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
Alio platform
Clinical Study ID
NCT06056739
AM23
Ages > 18 All Genders
Study Summary
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 StatesActive - Recruiting

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