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Clinical Performance and Safety Comparison of Stay Safe Link® With Stay Safe® in Patient on CAPD (CAPD-3)

NCT03177031 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 472

Last updated 2019-10-03

No results posted yet for this study

Summary

This post-marketing study is undertaken to compare the clinical effectiveness and safety of two continuous ambulatory peritoneal dialysis produced by Fresenius Medical Care (FMC), i.e. Stay Safe® (STS) that is produced by a plant in Germany and Stay Safe Link® (SSL) that is produced in Malaysia. The study is an open labelled, randomised controlled trial where 434 patients in total will be randomised to either STS or SSL in a 1:1 ratio.

Conditions

  • Continuous Ambulatory Peritoneal Dialysis

Interventions

DEVICE

Stay Safe Link (SSL)

CAPD system produced in Malaysia by Fresenius Medical Care

DEVICE

Stay Safe (STS)

CAPD system produce in Germany by Fresenius Medical Care

Sponsors & Collaborators

  • Penang Hospital, Malaysia

    lead OTHER_GOV

Principal Investigators

  • Loke Meng Ong · Clinical Research Centre, Penang General Hospital, Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-13
Primary Completion
2019-04-30
Completion
2019-06-26

Countries

  • Malaysia

Study Locations

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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 NCT03177031 on ClinicalTrials.gov