Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581393
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
First Evaluation of the Moda-Flx Hemodialysis System in Real World Clinical Settings
Sponsor:
None
Organization:
None
Study Overview
Official Title:
First Evaluation of the Moda-Flx Hemodialysis System in Real World Clinical Settings
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a non-significant risk study utilizing a device cleared for use by the FDA under its 510k clearance Consented patients will complete their usual dialysis treatment under professional care in an ICHD In-Center Hemodialysis setting
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None