The Jordan Study for End-Stage Renal Disease Subjects

June 20, 2024 updated by: Alio, Inc.

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

To compare the Alio device to blood draws.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Jordan
      • Amman, Jordan, 11195
        • Recruiting
        • Jordan Center for Pharmaceutical Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESKD Subjects
Non-invasive device worn over vasculature.
Device: Alio Device
Non-invasive device worn over vasculature.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alio, Inc.

Investigators

  • Principal Investigator: Tawfiq Arafat, MD, Alkhansaa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2022

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

April 2, 2022

First Submitted That Met QC Criteria

May 17, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 20, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AM14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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