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

Sponsor
Fresenius Medical Care Deutschland GmbH
Study ID
NCT06390592
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PD cycler — DEVICE
    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)

Study Details

Analysis and comparison of treatments with and without the FlexPoint technology (flexible volume and dwell time management) of the PD cycler sleep•safe harmony

Key Dates

First listed
Apr 30, 2024
Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Feb 28, 2027
Completion
May 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Other: Peritoneal dialysis (PD)
    During the clinical phase, patients are treated continuously with the PD cycler sleep•safe harmony. The total duration of the clinical phase is six weeks and is divided into 3 Phases à 2 weeks (Clinical phase I, II, and III) which only differ in the 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)

Primary Outcome Measure

Total Kt/V urea [ Time Frame: every 2 weeks, during the 6 weeks treatment ]

Central Contacts

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