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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Powerme midline catheter | Experimental | Powerme midline catheter |
|
| peripheral intravenous catheter | Sham Comparator | BD Pegusas peripheral intravenous catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| catheter placement | Device | catheter placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | First day, during catheter insertion |
| Indwelling time |
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Inclusion Criteria:
Exclusion Criteria:
Coagulation disorder or active bleeding;
Skin injury, infection, or dermatosis at the site to be punctured;
History of radiotherapy, thrombosis, or vascular surgery; arteriovenous fistula or phlebitis history at the area and/or vein to be catheterized;
History of mental illness;
End stage renal disease requires vein protection;
Conditions with decreased venous flow in the extremity, such as lymphedema of the arm, etc.;
Infusions of vesicant or irritant drugs, hyperosmotic infusate (the osmotic pressure >900mOsm/L in this study), parenteral nutrition, etc., which are not suitable for peripheral intravenous infusion (If other appropriate venous access is established for the aforementioned infusates, the patient may be enrolled).
The evaluation of the upper limb veins is Grade II, the evaluation grade is as following:
Self-reported being pregnant or lactating;
Other conditions that the investigator considers improper for the study;
Participating in another study or already enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Xuying Li, RN | Hunan Cancer Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Changsha | China | ||||
| Shanghai First General Hospital |
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PowerMe Midline
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The retention time of the IV catheter system of each subject after successful insertion.
| 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". | 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. | up to 28 days |
| Incidence of accidental dislodgement | Unintentional premature removal of the catheter from the vessel. | up to 28 days |
| Incidence of phlebitis | Incidence of phlebitis | up to 28 days |
| Incidence of adverse events | Incidence of adverse events | up to 28 days |
| Incidence of serious adverse events | Incidence of serious adverse events | up to 28 days |
| Shanghai |
| 200040 |
| China |
| Shanghai Ninth People's Hospital | Shanghai | China |
| The First Affiliated Hospital of Soochow University | Suzhou | China |