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)
1 other identifier
interventional
75
1 country
1
Brief Summary
To compare the Alio device to blood draws.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 21, 2022
CompletedFirst Submitted
Initial submission to the registry
April 2, 2022
CompletedFirst Posted
Study publicly available on registry
May 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedJune 21, 2024
June 1, 2024
2.6 years
April 2, 2022
June 20, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (1)
ESKD Subjects
EXPERIMENTALNon-invasive device worn over vasculature.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alio, Inc.lead
Study Sites (1)
Jordan Center for Pharmaceutical Research
Amman, 11195, Jordan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tawfiq Arafat, MD
Alkhansaa Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2022
First Posted
May 19, 2022
Study Start
March 21, 2022
Primary Completion
November 1, 2024
Study Completion
November 1, 2024
Last Updated
June 21, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share