Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05039541 |
Other study ID # |
GW-12 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 1, 2022 |
Est. completion date |
April 20, 2022 |
Study information
Verified date |
September 2023 |
Source |
Alio, Inc. |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
There will be two phases of this study. The phases of this study may occur simultaneously. In
Phase I, eligible subjects will be asked to acutely wear the Alio Medical RMS SmartPatch
during regularly scheduled dialysis sessions. Subjects will have a pre- and post-dialysis
blood draw(s), vitals collected, and monitoring throughout the dialysis sessions. The
SmartPatch will be removed from the location(s) where it is placed following the
post-dialysis blood draw.
In Phase II, subjects will be asked to wear a SmartPatch for up to 90 days. Subjects will be
trained on the use of the Alio Medical RMS and be provided a system for them to utilize at
home. Patches will be changed at a minimum of once every 7 days.
Description:
There will be two phases of this study. The phases of this study may occur simultaneously.
For Phase I subjects' consent will be completed via RedCap in person upon their first study
related dialysis visit. In Phase I, eligible subjects will be asked to acutely wear the Alio
Medical RMS SmartPatch during regularly scheduled dialysis sessions.The SmartPatch
automatically records data and uploads it to the Alio Cloud. Subjects will have a pre- and
post-dialysis blood draw(s), vitals collected, and monitoring throughout the dialysis
sessions. The SmartPatch will be removed from the location(s) where it is placed following
the post-dialysis blood draw.
For Phase II consent will be completed via RedCap either in clinic during a visit to pick up
supplies or via email and digital communication if the subject is unable to drive to the
clinic location. In Phase II, subjects will be asked to wear a SmartPatch for up to 90 days.
The exact wear time will be documented on the case report form (CRF). Any request for
specific wear times and frequency of SmartPatch changes will be documented prior to study
start on the consent form or CRF. This will be done to enable continuous non-invasive
measurements of the patient metrics (e.g., hemoglobin (Hb), hematocrit (Hct),heart rate (HR),
and other relevant dialysis labs or vitals). Subjects will be trained on the use of the Alio
Medical RMS and be provided a system for them to utilize at home. Patches will be changed at
a minimum of once every 7 days.
In addition to At-Home device use, subjects will also be participating in acute data
collection during one (or more) of their in-clinic or at home dialysis sessions.
Approximately every two to four weeks over the course of Phase 2, subjects will have a pre-
and post-dialysis blood draw(s), vitals collected, and SmartPatch monitoring.
Further, any procedures, hospitalizations or additional relevant labs/imaging will also be
collected for the purposes of comparing the Alio Medical RMS to standard of care assessments.
At the end of the study, subjects maybe asked to complete a short survey on their experience
with the Alio Medical RMS. Select study staff will have access to Alio Medical RMS study data
for the purposes of comparing this information to the clinical standard(s) collected.