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Procedure

Hemodialysis System for Kidney Disease

N/A
Waitlist Available
Research Sponsored by Diality Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a diagnosis of end stage kidney disease (ESKD) adequately treated by maintenance dialysis (defined as achieving a spKt/V ≥ 1.2 OR stdKt/V ≥ 2.1) and be deemed stable by their treating nephrologist prior to consent
Be older than 18 years old
Must not have
Have a significant cognitive impairment that would preclude informed consent or the capacity for completing dialysis as prescribed by their treating nephrologist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up samples will be collected before and after each dialysis treatment at visit 1, visit 2, visit 3 and at visit 4 over a two week period
Awards & highlights

Summary

This trial involves using a device that has been approved by the FDA for use in dialysis treatment. Patients who agree to participate will receive their regular dialysis treatment in a professional healthcare setting.

Who is the study for?
This trial is for patients with various stages of kidney disease, including those experiencing chronic kidney failure. Participants must be currently receiving in-center hemodialysis treatments and are willing to complete their usual dialysis using the Moda-Flx Hemodialysis System under professional supervision.
What is being tested?
The study is evaluating the performance of the Moda-Flx Hemodialysis System™ in a real-world clinical setting. Patients will undergo their regular dialysis sessions using this FDA-cleared device to assess its safety and effectiveness during standard treatment.
What are the potential side effects?
Since the trial involves a device already cleared by the FDA and not a new medication, side effects may relate more to typical risks associated with standard hemodialysis procedures rather than specific issues caused by the Moda-Flx system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have end-stage kidney disease and am on stable dialysis treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am able to understand and follow my dialysis treatment plan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~samples will be collected before and after each dialysis treatment at visit 1, visit 2, visit 3 and at visit 4 over a two week period
This trial's timeline: 3 weeks for screening, Varies for treatment, and samples will be collected before and after each dialysis treatment at visit 1, visit 2, visit 3 and at visit 4 over a two week period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in Blood Chemistry
Changes in Complete Blood Count
Changes in Iron Studies
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Professional Care in an In-Center Hemodialysis SettingExperimental Treatment1 Intervention
Hemodialysis using the Moda-flx Hemodialysis System

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Who is running the clinical trial?

Diality Inc.Lead Sponsor
Osman Khawar, MDStudy DirectorDiality Inc.
1 Previous Clinical Trials
30 Total Patients Enrolled
~0 spots leftby Oct 2024
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