catheter placement
Devicecatheter placement
NCT Number: NCT04719377
This study is designed to evaluate the effectiveness and the safety of the PowerMeTM Midline Catheter in the Chinese population.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Hunan Cancer Hospital, Changsha, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
catheter placement
Time frame: up to 28 days
After the placement of the IV catheter system, the study nurse shall answer "yes/no" to the following questions:
After the removal of the IV catheter system, the study nurse shall answer "yes/no" to the following questions:
Time frame: First day, during catheter insertion
Successful first insertion means the IV catheter system can be successfully inserted into the blood vessel on the first insertion.
Time frame: up to 28 days
The retention time of the IV catheter system of each subject after successful insertion.
Time frame: up to 28 days
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
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
Unintentional premature removal of the catheter from the vessel.
Time frame: up to 28 days
Incidence of phlebitis
Time frame: up to 28 days
Incidence of adverse events
Time frame: up to 28 days
Incidence of serious adverse events
Becton, Dickinson and Company
Industry
A Prospective, Multi-center, Open-label, Randomized, Controlled Non-inferiority Clinical Trial Evaluating the Effectiveness and Safety of the PowerMe Midline Catheter Versus Traditional PIV in the Chinese Population
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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