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Safety, Effectiveness and Manipulability Evaluation of a Domestic PD Machine

NCT02525497 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2019-12-11

No results posted yet for this study

Summary

This study is a randomized, multi-center，crossover study of a domestic FM peritoneal dialysis machine and Baxter HOMECHOICE.It aims to verify safety, effectiveness and manipulability of a domestic peritoneal dialysis machine.

Conditions

  • Kidney Failure,Chronic

Interventions

DEVICE

FM peritoneal dialysis machine

FM peritoneal dialysis machine APD 10L/10h

DEVICE

HOMECHOICE peritoneal dialysis machine

HOMECHOICE peritoneal dialysis machine APD 10L/10h

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • CHEN Xiangmei, yes · Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • China

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 NCT02525497 on ClinicalTrials.gov