Status:
UNKNOWN
Alio WEAR Study: Long-term Wear of the Alio Platform
Lead Sponsor:
Alio, Inc.
Conditions:
End Stage Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The WEAR study is long-term interventional study designed to evaluate patient and clinician use of the Alio platform, per its FDA cleared indications.
Eligibility Criteria
Inclusion
- At least 18 years of age.
- Receiving hemodialysis via an AVF or AVG in an arm location at the time of study start.
- Able to wear the SmartPatch effectively at the specified location on the arm.
- Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
- Willing and able to wear the SmartPatch as instructed and comply with all interviews, surveys and questionnaires, and schedule of evaluations.
Exclusion
- Skin near the proximity of the AV access that is chronically swollen, infected, inflamed, open wounds, lesions, or has skin eruptions.
- Participation in any other clinical trials involving investigational or marketed products that in the opinion of the investigator could affect the quality of the data.
- Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
Key Trial Info
Start Date :
October 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06056739
Start Date
October 9 2023
End Date
April 1 2024
Last Update
October 11 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Site 1
Huntley, Illinois, United States, 60142