Long-term use of the Alio platform for patients with end-stage kidney disease
Alio WEAR Study: Long-term Wear of the Alio Platform
This study is testing if the Alio platform, which includes a SmartPatch device, can help people on hemodialysis manage their treatment better over the long term.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alio, Inc. Industry-sponsored |
| Locations | 1 site (Huntley, Illinois) |
| Trial ID | NCT06056739 on ClinicalTrials.gov |
What this trial studies
The WEAR study is an interventional study aimed at evaluating the long-term use of the Alio platform by patients and clinicians. Participants will be individuals receiving hemodialysis through an arteriovenous fistula or graft, who will wear the SmartPatch device as part of their treatment. The study will assess the effectiveness and usability of the device in a real-world setting, focusing on patient compliance and outcomes over time.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are currently receiving hemodialysis via an AVF or AVG.
Not a fit: Patients with skin issues near their AV access or those participating in other conflicting clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of end-stage kidney disease by improving patient experience and treatment outcomes.
How similar studies have performed: While the specific approach of the Alio platform is novel, similar studies evaluating wearable health technology have shown promising results in improving patient care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Huntley, Illinois
- Site 1 — Huntley, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Amy Steig
- Email: amy@alio.ai
- Phone: 4158348031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.