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The ReModel IHC Study for ESRD Patients

NCT05039541 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-09-22

No results posted yet for this study

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.

Conditions

  • Dialysis Access Malfunction

Interventions

DEVICE

Alio Device

Subjects will wear the Alio device over their vasculature.

Sponsors & Collaborators

  • Alio, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Kraus, MD · Intermountain Health Care

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2022-04-20
Completion
2022-04-20
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05039541 on ClinicalTrials.gov