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Alio Device Wear for Chronic Kidney Failure

N/A

Recruiting

Research Sponsored by Alio, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Receiving hemodialysis via an AVF or AVG in an arm location at the time of study start

At least 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial studies how a device called Alio helps patients and doctors. It has been approved by the FDA.

Who is the study for?

This trial is for adults over 18 with kidney disease who are on hemodialysis via an arm access point. Participants must be able to wear the Alio SmartPatch on their arm, follow study instructions, and complete surveys. People with skin issues near the dialysis site or those in other trials that might affect results can't join.Check my eligibility

What is being tested?

The WEAR study tests long-term use of the Alio platform—a device worn like a patch—to monitor health data in patients with kidney failure. It checks how well patients and doctors can use it according to FDA guidelines.See study design

What are the potential side effects?

Since this trial involves wearing a monitoring device (the Alio SmartPatch), side effects may include potential skin irritation or discomfort at the patch application site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am currently on hemodialysis with a fistula or graft in my arm.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessing usage of the Alio platform by the test subject

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Test SubjectExperimental Treatment1 Intervention

All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Alio platform.

Group II: Control SubjectActive Control1 Intervention

All subjects who are enrolled into the control group and participate in data collection will not receive the noninvasive Alio platform.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alio, Inc.Lead Sponsor

1 Previous Clinical Trials

12 Total Patients Enrolled

David Whittaker, MDStudy DirectorAlio

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies left in this examination for participants?

"Affirmative. Clinicaltrials.gov confirms that this experiment is actively looking for enrollees, which was initially posted on 1st November 2023 and most recently updated on 21st September 2023. 250 people are required to partake from a single site."

Answered by AI

How many participants has this clinical trial onboarded thus far?

"Affirmative. The information posted on clinicaltrials.gov verifies that this research initiative is actively recruiting participants; the trial was initially made available to potential patients on November 1st 2023, and a recent update occurred September 21st of the same year. 250 individuals are required for enrollment from one medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Alio WEAR Study: Long-term Wear of the Alio Platform

2023. "Alio WEAR Study: Long-term Wear of the Alio Platform". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06056739.