End Stage Kidney DiseaseNCT06056739
Alio WEAR Study: Long-term Wear of the Alio Platform
A study testing Alio platform in people with End Stage Kidney Disease, run by Alio, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Kidney Disease
- What is being tested?
- Alio platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2023to 1 Apr 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Site 1
Huntley, Illinois, 60142
Stacey Miller, stacey@alio.ai
About this study
The WEAR study is long-term interventional study designed to evaluate patient and clinician use of the Alio platform, per its FDA cleared indications.
- Conditions
- End Stage Kidney Disease
- Being tested
- Alio platform
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alio platformDevice
Remote monitoring platform
| Study group | Role | What they receive |
|---|---|---|
| Test Subject | Experimental | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Alio platform. Receives: Device: Alio platform |
| Control Subject | No intervention | All subjects who are enrolled into the control group and participate in data collection will not receive the noninvasive Alio platform. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing usage of the Alio platform by the test subject
Assessing compliance and ease of use via surveys
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start9 Oct 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Kidney DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Whittaker, MD, Study director, Alio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056739
- Sponsor's protocol ID
- AM23
- Status last verified
- Oct 2023
- First submitted
- 21 Sep 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alio WEAR Study: Long-term Wear of the Alio Platform
- ClinicalTrials.gov ID
- NCT06056739
- Acronym / sponsor ID
- AM23
- Conditions
- End Stage Kidney Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Alio, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 28 Sep 2023 (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.
The WEAR study is long-term interventional study designed to evaluate patient and clinician use of the Alio platform, per its FDA cleared indications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Subject | Experimental | Device: Alio platformAll subjects who are enrolled into the test group and participate in data collection receive the noninvasive Alio platform. |
| Control Subject | No intervention | –All subjects who are enrolled into the control group and participate in data collection will not receive the noninvasive Alio platform. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 platformRemote monitoring platform | Device | Test Subject |
Primary outcome
Assessing usage of the Alio platform by the test subject
Time frame: Up to 1 year
Assessing compliance and ease of use via surveys
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
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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.
David Whittaker, MD study director
Alio
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 platform in people with End Stage Kidney Disease, 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amy Steig (4158348031, amy@alio.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing usage of the Alio platform by the test subject (time frame: Up to 1 year). 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 11 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.