- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05763147
Study of BD Pre-filled Flush Syringes in China
A Prospective, Multi-center, Randomized, Open Label, Controlled Trial of BD Pre-filled Flush Syringes
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Justina Zhu
- Phone Number: 08621-62344853
- Email: justina.zhu@bd.com
Study Contact Backup
- Name: Wendy Shan
- Phone Number: 08610-58139094
- Email: wendy.shan@bd.com
Study Locations
-
-
-
Beijing, China, 200040
- Recruiting
- Beijing Friendship Hospital
-
Contact:
- Jinkai Luo
- Phone Number: 08610-63139021
- Email: jinkai1023@163.com
-
Beijing, China, 200040
- Recruiting
- Beijing Hospital
-
Contact:
- Chao Sun
- Phone Number: 0861085138594
- Email: sunchaobjyy@163.com
-
Beijing, China, 200040
- Recruiting
- Beijing Jishuitan Hospital
-
Contact:
- Xuemei Lu
- Phone Number: 08610-58516783
- Email: lxm1236@sina.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PosiFlush™ Pre-filled flush syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.)
|
locking and flushing the end of catheter line at the intervals of different drug treatment.
|
Active Comparator: PosiFlush™ Pre-filled Flush Syringes (BD, USA)
|
locking and flushing the end of catheter line at the intervals of different drug treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the overall performance for flushing and / or locking the catheters.
Time Frame: immediately after treatment
|
Composite score using a 5-question nurse survey:
|
immediately after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Device ease of use
Time Frame: immediately after treatment
|
Nurse questionnaire: 1) Is the plunger easy to push forward when flushing or locking? |
immediately after treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events and serious adverse events
Time Frame: 1 hour after treatment
|
Incidence of adverse events and serious adverse events
|
1 hour after treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chao Chao, Beijing Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDS-21FLUSHCN01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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