The ReModel IHC Study for ESRD Patients

NCT05039541 | Completed FDA Device

• 1 other identifier: GW-12
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vascular access monitoring

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

ESRD Patients

EXPERIMENTAL

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

Interventions

Alio Device DEVICE

Subjects will wear the Alio device over their vasculature.

ESRD Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Alio, Inc.: lead

Study Sites (1)

Intermountain Dialysis

Murray, Utah, 84107, United States

Location

Study Officials

• Mark Kraus, MD

  Intermountain Health Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: September 9, 2021
• Study Start: March 1, 2022
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)