The Jordan Study for End-Stage Renal Disease Subjects

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05382663
• Other study ID #: AM14
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: November 1, 2024

Study information

• Verified date: June 2024
• Source: Alio, Inc.
• Contact: Emilee Scates
• Phone: 7203120218
• Email: emilee[@]alio.ai
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the Alio device to blood draws.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Device:
• Alio Device
Non-invasive device worn over vasculature.

Locations

Country	Name	City	State
Jordan	Jordan Center for Pharmaceutical Research	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Alio, Inc.

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 1 year
Primary	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.	through study completion, an average of 1 year