An interventional study of catheter placement in Catheterization, sponsored by Becton, Dickinson and Company. Completed at 4 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-23.
Sponsored by Becton, Dickinson and Company · Not applicable, Interventional, and Treatment
This study is designed to evaluate the effectiveness and the safety of the PowerMeTM Midline Catheter in the Chinese population.
This is a prospective, multi-center, open-label, randomized, controlled, non-inferiority clinical trial designed to evaluate the effectiveness and the safety of the PowerMeTM Midline Catheter compared to PIVC in the Chinese population in order to support the product's registration in China.
Becton, Dickinson and Company is the lead sponsor of 60 studies on the registry; 5 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The evaluation of the upper limb veins is Grade II, the evaluation grade is as following:
Powerme midline catheter
Device: catheter placement
BD Pegusas peripheral intravenous catheter
Device: catheter placement
catheter placement
Acceptance of the overall performance of the IV catheter system
After the placement of the IV catheter system, the study nurse shall answer "yes/no" to the following questions: 1. Can the IV catheter system vent the air properly; 2. Can the IV catheter system be inserted and be placed in the blood vessel; 3. Can the needle tube be withdrawn from the septum; After the removal of the IV catheter system, the study nurse shall answer "yes/no" to the following questions: 4. Can the IV catheter system be removed properly; 5. There is no leakage during the application of the IV catheter system (including the processes of venting, infusion, flushing and sealing, and indwelling).
Time frame: up to 28 days
Success rate of the first insertion of the catheter
Successful first insertion means the IV catheter system can be successfully inserted into the blood vessel on the first insertion.
Time frame: First day, during catheter insertion
Indwelling time
The retention time of the IV catheter system of each subject after successful insertion.
Time frame: up to 28 days
Rate of good performance of the pinch clamp
If the pinch clamp can close and open the tubing properly, performance of the pinch clamp can be evaluated as "good".
Time frame: up to 28 days
Incidence of catheter blockage
The catheter system is blocked, causing the system to fail to infuse the fluid after it is connected to the infusion set/syringe.
Time frame: up to 28 days
Incidence of accidental dislodgement
Unintentional premature removal of the catheter from the vessel.
Time frame: up to 28 days
Incidence of phlebitis
Incidence of phlebitis
Time frame: up to 28 days
Incidence of adverse events
Incidence of adverse events
Time frame: up to 28 days
Incidence of serious adverse events
Incidence of serious adverse events
Time frame: up to 28 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Becton, Dickinson and Company