Evaluation of Domestic Hemodialysis Machine: A Multi-cent... | NCT02904343

Studies
Evaluation of Domestic Hemodialysis Machine: A Multi-center Clinical Study

NCT02904343

Sponsor

Chinese PLA General Hospital

Status

Withdrawn

Last Update Posted

Jun 26, 2018Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Hemodialysis

Interventions

domestic hemodialysis machine
imported hemodialysis machine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The sponsors want to stop the study.

Expanded Access Info

Start Date

Sep 2017Estimated

Primary Completion Date

Oct 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Aug 22, 2016

First Submission Date that Met QC Criteria

Sep 15, 2016

First Posted Date

Sep 16, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2018

Last Update Posted Date

Jun 26, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiangmei Chen, Professor,Chief physician,Academician of Chinese Academy of Engineering, Chinese PLA General HospitalPrincipal Investigator

Lead Sponsor

Chinese PLA General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

An important reason for the costs of hemodialysis treatment in China are expensive is the hemodialysis machine and related products mainly rely on imports. Hemodialysis machine is the basis equipment of the hemodialysis treatment. After years of research and development, China has had the domestic hemodialysis machine. However, due to the lack of control studies of domestic and imported hemodialysis machine, thus causing the domestic hemodialysis machine promotion has been hindered. The aim of this study is to verify the quality and safety of domestic hemodialysis machine.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group of domestic hemodialysis machine	Experimental		Device: domestic hemodialysis machine
Group of imported hemodialysis machine	Active Comparator		Device: imported hemodialysis machine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
domestic hemodialysis machine	Device	WEGO, DBB-27C	Group of domestic hemodialysis machine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse reactions associated with the use of dialysis machines		0 to 3 months

Secondary Outcomes

Measure	Description	Time Frame
The results of endotoxin level of dialysate	endotoxin level of dialysis fluid at outlet	0,1,2,3 months
The results of bacterial culture of dialysate	bacterial culture of dialysis fluid at outlet

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age≥18, male or female
Maintenance hemodialysis duration>3 months
Regular hemodialysis,3 times a week,4 hours per session
Sign the written informed consent

Exclusion Criteria:

Acute kidney injury
Prepare to transfer to kidney transplantation or peritoneal dialysis in a year.
Positive in Hepatitis B virus, hepatitis C virus, syphilis or HIV
Pregnancy or lactation
Under other drug trial
Acute infection, severe heart, lung, liver, nervous diseases, malignant tumor
Can not be treated in accordance with the research program

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided