RecruitingNot ApplicableNCT05382663

The Jordan Study for End-Stage Renal Disease Subjects

Non-Invasive Monitoring of End-Stage Renal Disease Subjects Using Alio Medical Remote Monitoring System (RMS)


Sponsor

Alio, Inc.

Enrollment

75 participants

Start Date

Mar 21, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

To compare the Alio device to blood draws.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • and older
  • maintenance dialysis for ESRD via AVF/AVG in an arm location for at least 6 months
  • written informed consent
  • able to wear the SmartPatch as instructed and follow study protocols

Exclusion Criteria6

  • Skin near the proximity of Patch placement is swollen, infected and/or inflamed
  • pregnancy
  • serious medical condition which in the opinion of the investigator may adversely affect the safety of the subject or the device being evaluated
  • AVF/AVG in a non-arm location
  • participants with novel indications for their AVG (ie. HeRO grafts)
  • participation in any other clinical trials that could affect the quality of study data

Interventions

DEVICEAlio Device

Non-invasive device worn over vasculature.


Locations(1)

Jordan Center for Pharmaceutical Research

Amman, Jordan

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NCT05382663


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