The Jordan Study for End-Stage Renal Disease Subjects

Alio, Inc.75 enrolled

Overview

To compare the Alio device to blood draws.

Eligible subjects who have signed a consent form will be asked to wear the Alio device at specified location(s) for up to four regularly scheduled dialysis sessions. The device will be placed and worn throughout the entire session. Subjects will have blood draws that will be used to compare to device metrics. Additional vitals and monitoring may happen throughout this study.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease

Interventions

Alio DeviceDEVICE

Non-invasive device worn over vasculature.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 and older * maintenance dialysis for ESRD via AVF/AVG in an arm location for at least 6 months * written informed consent * able to wear the SmartPatch as instructed and follow study protocols Exclusion Criteria: * Skin near the proximity of Patch placement is swollen, infected and/or inflamed * pregnancy * serious medical condition which in the opinion of the investigator may adversely affect the safety of the subject or the device being evaluated * AVF/AVG in a non-arm location * participants with novel indications for their AVG (ie. HeRO grafts) * participation in any other clinical trials that could affect the quality of study data

Locations (1)

Jordan Center for Pharmaceutical Research

Amman, Jordan

RECRUITING

Outcomes

Primary Outcomes

1.Alio Device comparison to Hct via blood draw

Compare the Alio device to dialysis clinic blood lab values drawn before and after dialysis. The Hematrocrit (%) value collected will be compared to the Alio device.

Time frame: through study completion, an average of 1 year

1.Alio Device comparison to K+ via blood draw

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.

Time frame: through study completion, an average of 1 year

Central Contacts

Emilee Scates

CONTACT

7203120218 emilee@alio.ai

Data from ClinicalTrials.gov

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