NCT06390592

Clinical Performance of the Therapy Option FlexPoint of the PD Cycler Sleep•Safe Harmony

Clinical Performance of the Therapy Option FlexPoint (Flexible Volume and Dwell Time Management) of the PD Cycler Sleep•Safe Harmony

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Fresenius Medical Care Deutschland GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Renal Failure
• Chronic Kidney Disease

Interventions

Type	Name	Description
DEVICE	PD cycler	Patients are treated continuously during Peritoneal dialysis with the PD cycler sleep•safe harmony with different FlexPoint settings. According to their randomization the patients are treated with Treatment A, B or C in a different order: * standard (default) FlexPoint settings (Treatment A) * minimum value FlexPoint settings (Treatment B) * maximum value for permitted peritoneal residual volume (50%) of FlexPoint settings (Treatment C)

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-02-01
• Completion: 2027-05-01
• First posted: 2024-04-30
• Last updated: 2026-04-13