Comparing the Alio device to blood draws for end-stage renal disease patients
Non-Invasive Monitoring of End-Stage Renal Disease Subjects Using Alio Medical Remote Monitoring System (RMS)
This study is testing if the Alio device can effectively monitor patients with end-stage renal disease during dialysis, compared to regular blood draws.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alio, Inc. Industry-sponsored |
| Locations | 1 site (Amman) |
| Trial ID | NCT05382663 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of the Alio device in monitoring patients with end-stage renal disease during dialysis sessions. Eligible participants will wear the device during up to four scheduled dialysis sessions, allowing for continuous monitoring. Blood samples will be collected to compare the metrics obtained from the device with traditional blood draw results. The study will also include additional vital sign monitoring throughout the sessions to ensure comprehensive data collection.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been on maintenance dialysis for at least six months.
Not a fit: Patients with infections or serious medical conditions that could compromise their safety or the study's integrity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more efficient method for monitoring patients undergoing dialysis.
How similar studies have performed: While this approach is innovative, it is not clear if similar studies have shown success, as this specific device comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amman
- Jordan Center for Pharmaceutical Research — Amman, Jordan (Recruiting)
Study contacts
- Principal investigator: Tawfiq Arafat, MD — Alkhansaa Hospital
- Study coordinator: Emilee Scates
- Email: emilee@alio.ai
- Phone: 7203120218
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.