End Stage Renal DiseaseNCT05382663
The Jordan Study for End-Stage Renal Disease Subjects
A study testing Alio Device in people with End Stage Renal Disease, run by Alio, Inc. at 1 site in Jordan.
Trial summary
To compare the Alio device to blood draws. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- 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
- 75 participants
- Where
- 1 siteJordan
- Study dates
- 21 Mar 2022to 1 Nov 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
Jordan Center for Pharmaceutical Research
Amman, 11195
Tawfiq Arafat, MD, 96265814953, t.arafat@jcpr-jo.com
About this study
Official title: Non-Invasive Monitoring of End-Stage Renal Disease Subjects Using Alio Medical Remote Monitoring System (RMS)
To compare the Alio device to blood draws.
Read the detailed description
Eligible subjects who have signed a consent form will be asked to wear the Alio device at specified location(s) for up to four regularly scheduled dialysis sessions. The device will be placed and worn throughout the entire session.
Subjects will have blood draws that will be used to compare to device metrics. Additional vitals and monitoring may happen throughout this study.
- Conditions
- End Stage Renal Disease
- Being tested
- Alio Device
- 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 DeviceDevice
Non-invasive device worn over vasculature.
| Study group | Role | What they receive |
|---|---|---|
| ESKD Subjects | Experimental | Non-invasive device worn over vasculature. Receives: Device: Alio Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Alio Device comparison to Hct via blood draw
Compare the Alio device to dialysis clinic blood lab values drawn before and after dialysis. The Hematrocrit (%) value collected will be compared to the Alio device.
Measured: through study completion, an average of 1 year
1.Alio Device comparison to K+ via blood draw
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 posted19 May 2022
- Study start21 Mar 2022
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 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 Renal 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tawfiq Arafat, MD, Principal investigator, Alkhansaa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382663
- Sponsor's protocol ID
- AM14
- Status last verified
- Jun 2024
- First submitted
- 2 Apr 2022
- Last updated
- 21 Jun 2024
- 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Monitoring of End-Stage Renal Disease Subjects Using Alio Medical Remote Monitoring System (RMS)
- ClinicalTrials.gov ID
- NCT05382663
- Acronym / sponsor ID
- AM14
- Conditions
- End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Alio, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 19 May 2022 (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.
To compare the Alio device to blood draws.
Detailed description
Eligible subjects who have signed a consent form will be asked to wear the Alio device at specified location(s) for up to four regularly scheduled dialysis sessions. The device will be placed and worn throughout the entire session.
Subjects will have blood draws that will be used to compare to device metrics. Additional vitals and monitoring may happen throughout this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESKD Subjects | Experimental | Device: Alio DeviceNon-invasive device worn over vasculature. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
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 DeviceNon-invasive device worn over vasculature. | Device | ESKD Subjects |
Primary outcome
1.Alio Device comparison to Hct via blood draw
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 Hematrocrit (%) value collected will be compared to the Alio device.
1.Alio Device comparison to K+ via blood draw
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- 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.
Tawfiq Arafat, MD principal investigator
Alkhansaa Hospital
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 End Stage Renal Disease, run by Alio, Inc. at 1 site in Jordan.
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 4 inclusion and 6 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 21 Jun 2024. 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 Jordan. 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 Emilee Scates (7203120218, emilee@alio.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.Alio Device comparison to Hct via blood draw (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 21 Jun 2024.