search
Back to results

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

Primary Purpose

End Stage Kidney Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alio platform
Sponsored by
Alio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for End Stage Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site 1Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Test Subject

Control Subject

Arm Description

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

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

Outcomes

Primary Outcome Measures

Assessing usage of the Alio platform by the test subject
Assessing compliance and ease of use via surveys

Secondary Outcome Measures

Full Information

First Posted
September 21, 2023
Last Updated
October 9, 2023
Sponsor
Alio, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT06056739
Brief Title
Alio WEAR Study: Long-term Wear of the Alio Platform
Official Title
Alio WEAR Study: Long-term Wear of the Alio Platform
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Kidney Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test Subject
Arm Type
Experimental
Arm Description
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Alio platform.
Arm Title
Control Subject
Arm Type
No Intervention
Arm Description
All subjects who are enrolled into the control group and participate in data collection will not receive the noninvasive Alio platform.
Intervention Type
Device
Intervention Name(s)
Alio platform
Intervention Description
Remote monitoring platform
Primary Outcome Measure Information:
Title
Assessing usage of the Alio platform by the test subject
Description
Assessing compliance and ease of use via surveys
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Steig
Phone
4158348031
Email
amy@alio.ai
First Name & Middle Initial & Last Name or Official Title & Degree
Tala Harake
Phone
9499235884
Email
tala@alio.ai
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Whittaker, MD
Organizational Affiliation
Alio
Official's Role
Study Director
Facility Information:
Facility Name
Site 1
City
Huntley
State/Province
Illinois
ZIP/Postal Code
60142
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacey Miller
Email
stacey@alio.ai

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs