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Study of BD Pre-filled Flush Syringes in China

Primary Purpose

Effectiveness and Safety of Pre-filled Flush Syringe

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intravenous Access Device Flushing
Sponsored by
Becton, Dickinson and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Effectiveness and Safety of Pre-filled Flush Syringe

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1. Age >or equal to 18, no limitation on gender; 2. Hospitalized patients; 3. Patients who are anticipated to need or have in situ vascular access catheter devices (This may include: Peripheral Intravenous Catheter (PIVC), Central Venous Catheter (such as peripherally inserted central catheter (PICC)); 4. Patients who are expected to require flushing the vascular access catheter with saline at the beginning, during, or end of infusion therapy, or who require to flush and/or lock vascular access catheters at the beginning, during, the end of drug therapy; 5. Patients who can understand the purpose of the trial, agree to participate in this clinical trial and voluntarily sign the informed consent form. Exclusion Criteria: 1. Patient reports pregnancy or lactation (self-report); 2. Subjects who are known to have blockage or recanalization of vascular access prior to this trial. 3. Subjects who are known to have uncomfortable symptoms such as redness and pain, or common complication associated with indwelling catheter such as phlebitis and infection at the localized insertion site prior to this trial. 4. Patient participating in another drug or medical device clinical trial at the time of consent or has participated in a drug or medical device clinical trial within three months before enrollment; 5. Any other situation that, in the option of the Investigator would make the patient considered unfit for this study.

Sites / Locations

  • Beijing Friendship HospitalRecruiting
  • Beijing HospitalRecruiting
  • Beijing Jishuitan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PosiFlush™ Pre-filled flush syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.)

PosiFlush™ Pre-filled Flush Syringes (BD, USA)

Arm Description

PosiFlush™ Pre-filled flush syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.)

PosiFlush™ Pre-filled Flush Syringes (BD, USA)

Outcomes

Primary Outcome Measures

the overall performance for flushing and / or locking the catheters.
Composite score using a 5-question nurse survey: Can air in the BD Pre-filled Flush Syringes be expelled successfully? Can BD Pre-filled Flush Syringes connected to the catheter smoothly? Can BD Pre-filled Flush Syringes flush and /or lock the catheter successfully? Can BD Pre-filled Flush Syringes disconnect from the catheters smoothly? Any leakage observed at any part of the Flush syringe at any time during the usage? Overall performance for locking and flushing the catheter deemed as "success" if Question 1 to 4 answered with "YES", and question 5 answered with "NO".

Secondary Outcome Measures

Device ease of use
Nurse questionnaire: 1) Is the plunger easy to push forward when flushing or locking?

Full Information

First Posted
February 28, 2023
Last Updated
July 5, 2023
Sponsor
Becton, Dickinson and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05763147
Brief Title
Study of BD Pre-filled Flush Syringes in China
Official Title
A Prospective, Multi-center, Randomized, Open Label, Controlled Trial of BD Pre-filled Flush Syringes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Becton, Dickinson and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is to compare the BD PosiFlush™ Pre-filled Flush Syringes (manufactured by BD, USA) and evaluate the effectiveness and safety of the pre-filled flush syringes (manufactured by Suzhou Becton Dickinson Medical Devices Co., Ltd.) for locking and flushing the end of catheter line in Chinese popluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effectiveness and Safety of Pre-filled Flush Syringe

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
378 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PosiFlush™ Pre-filled flush syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.)
Arm Type
Experimental
Arm Description
PosiFlush™ Pre-filled flush syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.)
Arm Title
PosiFlush™ Pre-filled Flush Syringes (BD, USA)
Arm Type
Active Comparator
Arm Description
PosiFlush™ Pre-filled Flush Syringes (BD, USA)
Intervention Type
Device
Intervention Name(s)
Intravenous Access Device Flushing
Intervention Description
locking and flushing the end of catheter line at the intervals of different drug treatment.
Primary Outcome Measure Information:
Title
the overall performance for flushing and / or locking the catheters.
Description
Composite score using a 5-question nurse survey: Can air in the BD Pre-filled Flush Syringes be expelled successfully? Can BD Pre-filled Flush Syringes connected to the catheter smoothly? Can BD Pre-filled Flush Syringes flush and /or lock the catheter successfully? Can BD Pre-filled Flush Syringes disconnect from the catheters smoothly? Any leakage observed at any part of the Flush syringe at any time during the usage? Overall performance for locking and flushing the catheter deemed as "success" if Question 1 to 4 answered with "YES", and question 5 answered with "NO".
Time Frame
immediately after treatment
Secondary Outcome Measure Information:
Title
Device ease of use
Description
Nurse questionnaire: 1) Is the plunger easy to push forward when flushing or locking?
Time Frame
immediately after treatment
Other Pre-specified Outcome Measures:
Title
Incidence of adverse events and serious adverse events
Description
Incidence of adverse events and serious adverse events
Time Frame
1 hour after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Age >or equal to 18, no limitation on gender; 2. Hospitalized patients; 3. Patients who are anticipated to need or have in situ vascular access catheter devices (This may include: Peripheral Intravenous Catheter (PIVC), Central Venous Catheter (such as peripherally inserted central catheter (PICC)); 4. Patients who are expected to require flushing the vascular access catheter with saline at the beginning, during, or end of infusion therapy, or who require to flush and/or lock vascular access catheters at the beginning, during, the end of drug therapy; 5. Patients who can understand the purpose of the trial, agree to participate in this clinical trial and voluntarily sign the informed consent form. Exclusion Criteria: 1. Patient reports pregnancy or lactation (self-report); 2. Subjects who are known to have blockage or recanalization of vascular access prior to this trial. 3. Subjects who are known to have uncomfortable symptoms such as redness and pain, or common complication associated with indwelling catheter such as phlebitis and infection at the localized insertion site prior to this trial. 4. Patient participating in another drug or medical device clinical trial at the time of consent or has participated in a drug or medical device clinical trial within three months before enrollment; 5. Any other situation that, in the option of the Investigator would make the patient considered unfit for this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justina Zhu
Phone
08621-62344853
Email
justina.zhu@bd.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy Shan
Phone
08610-58139094
Email
wendy.shan@bd.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chao Chao
Organizational Affiliation
Beijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Friendship Hospital
City
Beijing
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinkai Luo
Phone
08610-63139021
Email
jinkai1023@163.com
Facility Name
Beijing Hospital
City
Beijing
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao Sun
Phone
0861085138594
Email
sunchaobjyy@163.com
Facility Name
Beijing Jishuitan Hospital
City
Beijing
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuemei Lu
Phone
08610-58516783
Email
lxm1236@sina.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of BD Pre-filled Flush Syringes in China

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