Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390592
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-25
Brief Title:
Clinical Performance of the Therapy Option FlexPoint of the PD Cycler SleepSafe Harmony
Sponsor:
Fresenius Medical Care Deutschland GmbH
Organization:
Fresenius Medical Care Deutschland GmbH
Study Overview
Official Title:
Clinical Performance of the Therapy Option FlexPoint Flexible Volume and Dwell Time Management of the PD Cycler SleepSafe Harmony
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FlexPoint
Brief Summary:
Analysis and comparison of treatments with and without the FlexPoint technology flexible volume and dwell time management of the PD cycler sleepsafe harmony
Detailed Description:
The primary objective of this study are
to investigate and compare the clinical performance of standard default FlexPoint settings to minimum FlexPoint settings and to the maximum value for permitted peritoneal residual volume of FlexPoint settings of the PD cycler sleepsafe harmony in the treatment of PD patients
to assess whether usage of the settings of the therapy option FlexPoint flexible volume and dwell time management of the PD cycler sleepsafe harmony that deviate from the system default and from former sleepsafe settings influences the efficacy of APD treatments as well as the hydration status by using BCM of PD patients
The secondary objectives of this study are
Patients Quality of Life QoL
Number of alarms
To investigate the effects on solute removal
To investigate the tolerability of the FlexPoint therapy options
Adverse events SAE
to investigate and compare the clinical performance of standard default FlexPoint settings to minimum FlexPoint settings and to the maximum value for permitted peritoneal residual volume of FlexPoint settings of the PD cycler sleepsafe harmony in the treatment of PD patients
to assess whether usage of the settings of the therapy option FlexPoint flexible volume and dwell time management of the PD cycler sleepsafe harmony that deviate from the system default and from former sleepsafe settings influences the efficacy of APD treatments as well as the hydration status by using BCM of PD patients
The secondary objectives of this study are
Patients Quality of Life QoL
Number of alarms
To investigate the effects on solute removal
To investigate the tolerability of the FlexPoint therapy options
Adverse events SAE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None