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NCT06581393 · ClinicalTrials.gov registry record · NA
First Evaluation of the Moda-Flx Hemodialysis System™ in Real World Clinical Settings
A NA study of End Stage Renal Disease and End-Stage Kidney Disease, sponsored by Diality.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT06581393: Completed NA study of End Stage Renal Disease and End-Stage Kidney Disease, sponsored by Diality.
NCT06581393 is a NA study of End Stage Renal Disease and End-Stage Kidney Disease that has completed, run by Diality. The registered enrollment target is 12 participants, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06581393, a NA study of End Stage Renal Disease and End-Stage Kidney Disease, has completed, sponsored by Diality.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Single-pool standardized dialysis adequacy (spKt/V) will be measured using the second-generation formula of Daugirdas. This formula normalizes urea clearance among heterogeneous hemodialysis schedules, where K=dialyzer clearance or urea, t=treatment time, and V=subject's volume of urea distribution. spKt/V values of ≥ 1.2 are regarded as being adequate.
Conditions Studied
Interventions
- DEVICE Moda-flx Hemodialysis System
Study Locations (1)
California
- North America Research Institute - Ontario
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-12-09 |
| Est. Completion | 2025-04-28 |
| Phase | NA |
What the finished NCT06581393 record still lists
NCT06581393 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with End Stage Renal Disease appearing as the primary indexed condition, and to 1 intervention - of which Moda-flx Hemodialysis System is the first listed.
NCT06581393 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06581393 about?
NCT06581393 is a clinical study titled "First Evaluation of the Moda-Flx Hemodialysis System™ in Real World Clinical Settings". 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.
What is the current status of trial NCT06581393?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2024-12-09. Estimated completion is 2025-04-28.
What conditions does trial NCT06581393 study?
This clinical trial studies the following conditions: End Stage Renal Disease, End-Stage Kidney Disease, End Stage Renal Disease on Dialysis.
What interventions are being tested in trial NCT06581393?
The interventions under investigation include: Moda-flx Hemodialysis System (DEVICE).
Who is sponsoring clinical trial NCT06581393?
This trial is sponsored by Diality, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06581393 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06581393's enrollment target sits among peer trials
12 75th of 86 higher than 10 of 86 other End Stage Renal Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other End Stage Renal Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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