Recruiting

Alio

Sponsor:

Alio, Inc.

Code:

NCT06056739

Conditions

End Stage Kidney Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Alio platform

Study Details

Brief 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.

Conditions

End Stage Kidney Disease

Study ID

NCT06056739

Start date

Oct 9, 2023

Status verified date

Oct, 2023

Completion date

Apr 1, 2024

Anticipated

Primary completion date

Apr 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Test Subject

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

no intervention: Control Subject

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

Interventions

Alio platform

Remote monitoring platform

Primary outcome measure

  • Assessing usage of the Alio platform by the test subject [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Amy Steig

4158348031amy@alio.ai

Tala Harake

9499235884tala@alio.ai

Locations

Site 1

Recruiting

Huntley, Illinois, United States, 60142

Contacts

Stacey Miller

stacey@alio.ai

More Information

Sponsor

Alio, Inc.

Last update posted

Oct 11, 2023

Last verified

Oct, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Alio, Inc. on 2023-10-11.