NCT05039541

The ReModel IHC Study for ESRD Patients

Feasibility Study: Using the Alio Medical REmoteMOnitoring System (RMS) to Non-InvasivelyMonitor Subjects With EnD-Stage REnaL DiseaseSubjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Alio, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dialysis Access Malfunction

Interventions

Type	Name	Description
DEVICE	Alio Device	Subjects will wear the Alio device over their vasculature.

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-04-20
• Completion: 2022-04-20
• First posted: 2021-09-09
• Last updated: 2023-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study