Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT06390592
Brief Summary:
Analysis and comparison of treatments with and without the FlexPoint technology (flexible volume and dwell time management) of the PD cycler sleep•safe 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 sleep•safe 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 sleep•safe harmony that deviate from the system default and from former sleep•safe 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:
NCT06390592
Study Brief:
Protocol Section:
NCT06390592