Status:
RECRUITING
The Jordan Study for End-Stage Renal Disease Subjects
Lead Sponsor:
Alio, Inc.
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05382663
Start Date
March 21 2022
End Date
November 1 2024
Last Update
June 21 2024
Active Locations (1)
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1
Jordan Center for Pharmaceutical Research
Amman, Jordan, 11195