The Jordan Study for End-Stage Renal Disease Subjects

Not Applicable

Recruiting

• Conditions: End Stage Renal Disease
• Interventions: Device: Alio Device

• Registration Number: NCT05382663
• Lead Sponsor: Alio, Inc.

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.

Study Timeline

• Study Start: 2022-03-21
• Study First Submitted: 2022-04-02
• Study First Submitted QC: 2022-05-17
• Study First Posted: 2022-05-19
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-21
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ESKD Subjects	Alio Device	Non-invasive device worn over vasculature.

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Jordan Center for Pharmaceutical Research; 🇯🇴 Amman, Jordan