Trials / Completed
CompletedNCT06581393
First Evaluation of the Moda-Flx Hemodialysis System™ in Real World Clinical Settings
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Diality Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Moda-flx Hemodialysis System | All participants will complete up to 4 dialysis treatments on the Moda-flx Hemodialysis System over a period of up to 2 weeks. |
Timeline
- Start date
- 2024-12-09
- Primary completion
- 2025-04-28
- Completion
- 2025-04-28
- First posted
- 2024-09-03
- Last updated
- 2025-06-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06581393. Inclusion in this directory is not an endorsement.