The Prognosis of Graft Using Plastic Cannula in Hemodialysis | NCT03645720

Studies
The Prognosis of Graft Using Plastic Cannula in Hemodialysis

NCT03645720

Sponsor

Hallym University Medical Center

Status

Withdrawn

Last Update Posted

Aug 3, 2022Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

End Stage Renal Failure on Dialysis

Interventions

Plastic cannula

Countries

South Korea

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

Aug 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

difficulty in performing study

Expanded Access Info

Start Date

Oct 22, 2018Actual

Primary Completion Date

May 2019Estimated

Completion Date

Jun 2019Estimated

First Submitted Date

Aug 21, 2018

First Submission Date that Met QC Criteria

Aug 22, 2018

First Posted Date

Aug 24, 2018Actual

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

Aug 1, 2022

Last Update Posted Date

Aug 3, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

choi sun ryoung, MD, Assistant professor, Hallym University Medical CenterPrincipal Investigator

Lead Sponsor

Hallym University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to evaluate the complication of the puncture related complication in AVG (arteriovenous graft) such as pseudoaneurysm and hematoma, and the dialysis adequacy using plastic cannula versus metal needle in hemodialysis patients

Detailed Description

Ultrasonography is performed to determine the maturity of vascular access 4 weeks after AVG creation.
The first puncture is performed with plastic cannula or metal needle when it is judged that the blood vessel has matured.
Four skilled nurses perform vascular access puncture with plastic or metal needle
Ultrasound are used to evaluate and record the complications related to the puncture in plastic or metal needle group every month.
Complications and dialysis adequacy between the two groups will be evaluated after 6 months

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
Metal needle gruop	No Intervention	puncture using metal needle
plastic cannula	Experimental	puncture using plastic cannula	Device: Plastic cannula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plastic cannula	Device	puncture using plastic cannula	plastic cannula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of pseudoaneurysm	critical puncture related complication in AVG	Incidence of pseudoaneurysm at 6 months

Secondary Outcomes

Measure	Description	Time Frame
punctutre related complication	hematoma, inflitration, thrombus	Monthly for 6 months.
Dialysis adeqaucy	Kt/V by serum test in two groups

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients receiving hemodialysis treatment using AVG

Exclusion Criteria:

Age under 20 years old or over 75 years old
Abnormal skin condition using immunosuppressants such as steroids.
Skin disorder
Metal allergy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sun Ryoung Choi, MD,PhD	Hallym University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hallym University Sacred Heart Hospital		Anyang-si	Gyeonggi-do	14066	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided