The Jordan Study for End-Stage Renal Disease Subjects

Non-Invasive Monitoring of End-Stage Renal Disease Subjects Using Alio Medical Remote Monitoring System (RMS)

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05382663

Enrollment

Registered

2022-05-19

Start date

2022-03-21

Completion date

2024-11-01

Last updated

2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Brief summary

To compare the Alio device to blood draws.

Detailed 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.

Interventions

DEVICEAlio Device

Non-invasive device worn over vasculature.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
1.Alio Device comparison to Hct via blood draw	through study completion, an average of 1 year	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.
1.Alio Device comparison to K+ via blood draw	through study completion, an average of 1 year	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.

Countries

Jordan

Contacts

Primary ContactEmilee Scates

emilee@alio.ai7203120218

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026