The ReModel IHC Study for ESRD Patients
Condition: Dialysis Access Malfunction
Study type: Interventional

Summary: 
      There will be two phases of this study. The phases of this study may occur simultaneously. In
      Phase I, eligible subjects will be asked to acutely wear the Alio Medical RMS SmartPatch
      during regularly scheduled dialysis sessions. Subjects will have a pre- and post-dialysis
      blood draw(s), vitals collected, and monitoring throughout the dialysis sessions. The
      SmartPatch will be removed from the location(s) where it is placed following the
      post-dialysis blood draw.

      In Phase II, subjects will be asked to wear a SmartPatch for up to 90 days. Subjects will be
      trained on the use of the Alio Medical RMS and be provided a system for them to utilize at
      home. Patches will be changed at a minimum of once every 7 days.
    

Detailed description: 
      There will be two phases of this study. The phases of this study may occur simultaneously.
      For Phase I subjects' consent will be completed via RedCap in person upon their first study
      related dialysis visit. In Phase I, eligible subjects will be asked to acutely wear the Alio
      Medical RMS SmartPatch during regularly scheduled dialysis sessions.The SmartPatch
      automatically records data and uploads it to the Alio Cloud. Subjects will have a pre- and
      post-dialysis blood draw(s), vitals collected, and monitoring throughout the dialysis
      sessions. The SmartPatch will be removed from the location(s) where it is placed following
      the post-dialysis blood draw.

      For Phase II consent will be completed via RedCap either in clinic during a visit to pick up
      supplies or via email and digital communication if the subject is unable to drive to the
      clinic location. In Phase II, subjects will be asked to wear a SmartPatch for up to 90 days.
      The exact wear time will be documented on the case report form (CRF). Any request for
      specific wear times and frequency of SmartPatch changes will be documented prior to study
      start on the consent form or CRF. This will be done to enable continuous non-invasive
      measurements of the patient metrics (e.g., hemoglobin (Hb), hematocrit (Hct),heart rate (HR),
      and other relevant dialysis labs or vitals). Subjects will be trained on the use of the Alio
      Medical RMS and be provided a system for them to utilize at home. Patches will be changed at
      a minimum of once every 7 days.

      In addition to At-Home device use, subjects will also be participating in acute data
      collection during one (or more) of their in-clinic or at home dialysis sessions.
      Approximately every two to four weeks over the course of Phase 2, subjects will have a pre-
      and post-dialysis blood draw(s), vitals collected, and SmartPatch monitoring.

      Further, any procedures, hospitalizations or additional relevant labs/imaging will also be
      collected for the purposes of comparing the Alio Medical RMS to standard of care assessments.
      At the end of the study, subjects maybe asked to complete a short survey on their experience
      with the Alio Medical RMS. Select study staff will have access to Alio Medical RMS study data
      for the purposes of comparing this information to the clinical standard(s) collected.
    

Intervention name(s): Alio Device
Intervention type(s): Device
Intervention description(s): Subjects will wear the Alio device over their vasculature.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: vascular access monitoring