Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613568
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Moda-flx Hemodialysis System Under Professional Care Settings by Trained Individuals and At Home by Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Non-Randomized Multicenter Open-Label Study Evaluating the Use of the Moda-flx Hemodialysis System Under Professional Care and At Home by Subjects With End Stage Kidney Disease ESKD Who Are on Stable Dialysis Regimens
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
The purpose of this study is to evaluate the safety and efficacy of the Moda-flx Hemodialysis System when used Under Professional Care Settings by trained individuals and At Home by trained Participants and Care Partners
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