The ReModel IHC Study for ESRD Patients

Completed · Not applicable

Conditions studied: Dialysis Access Malfunction

In brief

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.

Key facts

Study ID

NCT05039541

Run by

Alio, Inc.

People needed

12

Starts

2022-03-01

Expected to finish

2022-04-20

Last updated by the study team

2023-09-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Intermountain Dialysis — Murray, Utah, United States

Full record on ClinicalTrials.gov

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