The Jordan Study for End-Stage Renal Disease Subjects | NCT05382663

Studies
The Jordan Study for End-Stage Renal Disease Subjects

NCT05382663

Sponsor

Alio, Inc.

Status

Unknown status

Last Update Posted

Jun 21, 2024Actual

Enrollment

75Estimated

Phase

Not Applicable

Conditions

End Stage Renal Disease

Interventions

Alio Device

Countries

Jordan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 21, 2022Actual

Primary Completion Date

Nov 1, 2024Estimated

Completion Date

Nov 1, 2024Estimated

First Submitted Date

Apr 2, 2022

First Submission Date that Met QC Criteria

May 17, 2022

First Posted Date

May 19, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2024

Last Update Posted Date

Jun 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ESKD Subjects	Experimental	Non-invasive device worn over vasculature.	Device: Alio Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alio Device	Device	Non-invasive device worn over vasculature.	ESKD Subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Emilee Scates	Contact	7203120218		emilee@alio.ai

Overall Officials

Name	Affiliation	Role
Tawfiq Arafat, MD	Alkhansaa Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jordan Center for Pharmaceutical Research	Recruiting	Amman		11195	Jordan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided