The Jordan Study for End-Stage Renal Disease Subjects

Alio, Inc.

Status: Enrolling

Conditions: End Stage Renal Disease

Treatments: Device: Alio Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05382663

AM14

Details and patient eligibility

About

To compare the Alio device to blood draws.

Full description

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

ESKD Subjects

Experimental group

Description:

Non-invasive device worn over vasculature.

Treatment:

Device: Alio Device