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Comparison of Efficacy and Tolerability of APD Treatment With Different PD Cyclers

NCT04749680 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-08-02

No results posted yet for this study

Summary

The study has been designed in order to investigate the performance and safety of the new Silencia PD cycler including the Silencia tubing system in comparison to the PD-Night and Homechoice PD cycler which are both well-established PD cyclers.

Conditions

Interventions

DEVICE

PD cycler Silencia

Treatment for 2 weeks either with PD-Night or Homechoice PD cycler (Comparators) depending on the previous Treatment ((clinical phase I). At the end of these 2 treatment weeks and a subsequent training phase which up to 3 weeks, treatment with the Silencia PD cycler for 2 further weeks (clinical phase II).

Sponsors & Collaborators

  • Winicker Norimed GmbH

    collaborator INDUSTRY

  • James Motta, Clinical Research Associate (CRA)

    collaborator UNKNOWN

  • Fresenius Medical Care Deutschland GmbH

    lead INDUSTRY

Principal Investigators

  • Eduardo Machuca, Dr · Fresenius Medical Care Chile S.A.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-31
Primary Completion
2021-10-12
Completion
2021-10-12

Countries

  • Chile

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04749680 on ClinicalTrials.gov