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Clinical Performance of the Therapy Option FlexPoint (Flexible Volume and Dwell Time Management) of the PD Cycler Sleep•Safe Harmony
Analysis and comparison of treatments with and without the FlexPoint technology (flexible volume and dwell time management) of the PD cycler sleep•safe harmony
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
December 1, 2025
Primary Completion Date
January 1, 2026
Completion Date
December 1, 2026
Last Updated
September 17, 2025
24
ESTIMATED participants
PD cycler
DEVICE
Lead Sponsor
Fresenius Medical Care Deutschland GmbH
Collaborators
NCT07241390
NCT06926660
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06717698