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NCT06390592Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 3 Sept 2026

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
24 (estimated)
First submitted
25 Apr 2024
Start date
Dec 2026
Primary completion date
Aug 2027
Lead sponsor
Fresenius Medical Care Deutschland GmbH
NCT number
NCT06390592

What you commit to

  • Study type: Interventional
  • Planned participants: 24
  • From Dec 2026 to the primary completion date, Aug 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous participation in the same study
  • Patients receiving polyglucose containing PD solution

Other illness

  • Any conditions which could interference with the patient's ability to comply with the study
  • Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg)
  • Respiratory or abdominal wall disease deemed to contraindicate intraperitoneal fill volume (FV) manipulation
  • Patients who suffer from peritonitis/exit site infection during the last 4 weeks

Age

  • Women of childbearing age without effective means of contraception, pregnancy (pregnancy test will be conducted at start and end of study) or lactation period

Other

  • Life expectancy \<3 months
  • Participation in an interventional clinical study during the preceding 90 days

Who the study is looking for

  • Informed consent signed and dated by study patient and investigator/ authorised physician
  • Minimum age of 18 years
  • CKD patients with indication for renal replacement therapy
  • Patients being treated with APD for at least 3 months
  • Patients using the sleep•safe harmony PD cycler (version 3.1)
  • Fluid status regularly monitored with Body Composition Monitor (BCM)
  • Proper functioning catheter
  • Intraperitoneal Pressure (IPP) ≤ 18 cm H2O
  • Ability to understand the nature and requirements of the study

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.