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

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.

Study Overview

• Status: Completed
• Conditions: Dialysis Access Malfunction
• Intervention / Treatment: Device: Alio Device

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Dialysis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18-80.
• Maintenance dialysis for ESRD for at least 6 months.
• Dialysis via an AVF or AVG in an arm location.
• Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
• Can speak, read and communicate in English.
• Willing and able to wear the SmartPatch as instructed and comply with the visits, tests, and schedule of evaluations.

Exclusion Criteria:

• Hospital admission within last 30 days which, in the opinion of the physician or study staff, could potentially affect the subject's ability to participate in the study procedures.
• Pseudoaneurysm on the measured AV access.
• Liver disease associated with serum albumin levels less than 35 g/L.
• History of acute illness episode that, in the opinion of their physician or study staff, could potentially affect study data being collected.
• Significant fluid overload (patient > 3kg above dialysis dry weight at start of dialysis session)
• Subjects with novel materials for their AVF or hAVG, such as HeRO grafts, chest-wall AVFs
• Subjects with rapid-use grafts (e.g., AVflo™ or Gore® Acuseal)
• Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study if, in the judgement of the study staff, participation in this study could potentially affect the quality of study 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.
• The Study Doctor(s) determine(s) that the subject is not eligible for participation in this research study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESRD Patients; ESDR Patients will wear the Alio Device over their vascular access for either I) the duration of their dialysis session in clinic or II) for a 90 day period.	Device: Alio Device; Subjects will wear the Alio device over their vasculature.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alio device comparison to Hct via blood draws	Compare the Alio device to dialysis clinic blood lab values drawn before and after dialysis. The Hematocrit value collected will be compared to the Alio device.	through study completion, an average of 1 year
Alio device comparison to K+ via blood draws	Compare the Alio device to dialysis clinic blood lab values drawn before and after dialysis. The Potassium value collected will be compared to the Alio device.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Alio, Inc.
• Investigators: Principal Investigator: Mark Kraus, MD, Intermountain Health Care

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): April 20, 2022
• Study Completion (Actual): April 20, 2022

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: vascular access monitoring
• Other Study ID Numbers: GW-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No