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

NCT06056739 | Unknown FDA Device

• 1 other identifier: AM23
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Assessing usage of the Alio platform by the test subject

  Assessing compliance and ease of use via surveys

  Up to 1 year

Study Arms (2)

Test Subject

EXPERIMENTAL

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

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.

Interventions

Alio platform DEVICE

Remote monitoring platform

Test Subject

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alio, Inc.: lead

Study Sites (1)

Site 1

Huntley, Illinois, 60142, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Whittaker, MD

  Alio

  STUDY DIRECTOR

Central Study Contacts

Amy Steig

CONTACT

4158348031; amy@alio.ai

Tala Harake

CONTACT

9499235884; tala@alio.ai

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: October 9, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

US (1)