NCT06581393Completed
First Evaluation of the Moda-Flx Hemodialysis System™ in Real World Clinical Settings
Source: ClinicalTrials.gov · Last updated 22 Jun 2025
Brief summary (registry, in English)
This is a non-significant risk study utilizing a device cleared for use by the FDA under its 510(k) clearance. Consented patients will complete their usual dialysis treatment under professional care in an ICHD (In-Center Hemodialysis) setting.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 26 Aug 2024
- Start date
- 9 Dec 2024
- Primary completion date
- 28 Apr 2025
- Lead sponsor
- Diality Inc.
- Diseases
- Chronic kidney disease
- NCT number
- NCT06581393
What you commit to
- Study type: Interventional
- Participants enrolled: 12
- From 9 Dec 2024 to the primary completion date, 28 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have a significant cognitive impairment that would preclude informed consent or the capacity for completing dialysis as prescribed by their treating nephrologist.
Other
- In the opinion of the treating nephrologist, any other reason in which study participation would result in undue risk, including but not limited to protocol required prescription parameters.
- Are contraindicated for or not indicated to use the Moda-flx Hemodialysis System™ according to the Instructions For Use (IFU).
Who the study is looking for
- 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.
- Must sign the informed consent and a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
- Understand the nature of the procedures and the requirements of the Study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| North America Research Institute Coordinator of this site? Confirm its status | Ontario | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.