Dialysis Access MalfunctionNCT05039541
The ReModel IHC Study for ESRD Patients
A study testing Alio Device in people with Dialysis Access Malfunction, run by Alio, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dialysis Access Malfunction
- What is being tested?
- Alio Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 20 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-80.
- Maintenance dialysis for ESRD for at least 6 months.
- Dialysis via an AVF or AVG in an arm location.
- Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
- Can speak, read and communicate in English.
- Willing and able to wear the SmartPatch as instructed and comply with the visits, tests, and schedule of evaluations.
Who cannot join
- Hospital admission within last 30 days which, in the opinion of the physician or study staff, could potentially affect the subject's ability to participate in the study procedures.
- Pseudoaneurysm on the measured AV access.
- Liver disease associated with serum albumin levels less than 35 g/L.
- History of acute illness episode that, in the opinion of their physician or study staff, could potentially affect study data being collected.
- Significant fluid overload (patient > 3kg above dialysis dry weight at start of dialysis session)
- Subjects with novel materials for their AVF or hAVG, such as HeRO grafts, chest-wall AVFs
Show all 10Show fewer
- Subjects with rapid-use grafts (e.g., AVflo™ or Gore® Acuseal)
- Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study if, in the judgement of the study staff, participation in this study could potentially affect the quality of study 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.
- The Study Doctor(s) determine(s) that the subject is not eligible for participation in this research study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study: Using the Alio Medical REmoteMOnitoring System (RMS) to Non-InvasivelyMonitor Subjects With EnD-Stage REnaL DiseaseSubjects
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.
Read the detailed 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.
- Conditions
- Dialysis Access Malfunction
- Being tested
- Alio Device
- Keywords
- vascular access monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alio DeviceDevice
Subjects will wear the Alio device over their vasculature.
| Study group | Role | What they receive |
|---|---|---|
| ESRD Patients | Experimental | ESDR Patients will wear the Alio Device over their vascular access for either I) the duration of their dialysis session in clinic or II) for a 90 day period. Receives: Device: Alio Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alio device comparison to Hct via blood draws
Compare the Alio device to dialysis clinic blood lab values drawn before and after dialysis. The Hematocrit value collected will be compared to the Alio device.
Measured: through study completion, an average of 1 year
Alio device comparison to K+ via blood draws
Compare the Alio device to dialysis clinic blood lab values drawn before and after dialysis. The Potassium value collected will be compared to the Alio device.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start1 Mar 2022
- Primary completion20 Apr 2022
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dialysis Access MalfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Kraus, MD, Principal investigator, Intermountain Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039541
- Sponsor's protocol ID
- GW-12
- Status last verified
- Sep 2023
- First submitted
- 18 Aug 2021
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study: Using the Alio Medical REmoteMOnitoring System (RMS) to Non-InvasivelyMonitor Subjects With EnD-Stage REnaL DiseaseSubjects
- ClinicalTrials.gov ID
- NCT05039541
- Acronym / sponsor ID
- GW-12
- Conditions
- Dialysis Access Malfunction
- Keywords
- vascular access monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Alio, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESRD Patients | Experimental | Device: Alio DeviceESDR Patients will wear the Alio Device over their vascular access for either I) the duration of their dialysis session in clinic or II) for a 90 day period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-80.
- Maintenance dialysis for ESRD for at least 6 months.
- Dialysis via an AVF or AVG in an arm location.
- Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
- Can speak, read and communicate in English.
Key exclusion criteria (10 listed)
- Hospital admission within last 30 days which, in the opinion of the physician or study staff, could potentially affect the subject's ability to participate in the study procedures.
- Pseudoaneurysm on the measured AV access.
- Liver disease associated with serum albumin levels less than 35 g/L.
- History of acute illness episode that, in the opinion of their physician or study staff, could potentially affect study data being collected.
- Significant fluid overload (patient > 3kg above dialysis dry weight at start of dialysis session)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alio DeviceSubjects will wear the Alio device over their vasculature. | Device | ESRD Patients |
Primary outcome
Alio device comparison to Hct via blood draws
Time frame: through study completion, an average of 1 year
Compare the Alio device to dialysis clinic blood lab values drawn before and after dialysis. The Hematocrit value collected will be compared to the Alio device.
Alio device comparison to K+ via blood draws
Time frame: through study completion, an average of 1 year
Compare the Alio device to dialysis clinic blood lab values drawn before and after dialysis. The Potassium value collected will be compared to the Alio device.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Kraus, MD principal investigator
Intermountain Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alio Device in people with Dialysis Access Malfunction, run by Alio, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alio device comparison to Hct via blood draws (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.