A Clinical Trial Evaluating the Effectiveness and Safety of the PowerMe Midline Catheter in the Chinese Population

Catheterization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04719377
• Other study ID #: CDC-19POWME01
• Status: Completed
• Phase: N/A
• Start date: January 13, 2021
• Est. completion date: January 30, 2022

Study information

• Verified date: September 2022
• Source: Becton, Dickinson and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the effectiveness and the safety of the PowerMeTM Midline Catheter in the Chinese population.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: January 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. =18 years of age;

2. Inpatient with a need for intravenous infusion for an expected period of more than 4 days but no more than 28 days;

3. The veins in the upper limbs is suitable for puncture and catheterization of both the investigational device and the control device;

4. Willing to provide written Informed Consent and complete the study per the protocol.

Exclusion Criteria:

1. Coagulation disorder or active bleeding;

2. Skin injury, infection, or dermatosis at the site to be punctured;

3. History of radiotherapy, thrombosis, or vascular surgery; arteriovenous fistula or phlebitis history at the area and/or vein to be catheterized;

4. History of mental illness;

5. End stage renal disease requires vein protection;

6. Conditions with decreased venous flow in the extremity, such as lymphedema of the arm, etc.;

7. 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).

8. The evaluation of the upper limb veins is Grade II, the evaluation grade is as

following:

• 0 Veins are obviously bulged on the skin surface. The veins are touchable, thick, straight, soft, elastic and fixed.
• I Veins are relatively full and faintly touchable. The veins are less elastic or slide easily.
• II Veins are not full or collapsed and untouchable. The veins are hard or sliding. Phlebitis.

9. Self-reported being pregnant or lactating;

10. Other conditions that the investigator considers improper for the study;

11. Participating in another study or already enrolled.

Related Conditions & MeSH terms

• Catheterization

Intervention

Device:
• catheter placement
catheter placement

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha
China	Shanghai First General Hospital	Shanghai
China	Shanghai Ninth People's Hospital	Shanghai
China	The First Affiliated Hospital of Soochow University	Suzhou

Sponsors (1)

Lead Sponsor	Collaborator
Becton, Dickinson and Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Can the IV catheter system vent the air properly; Can the IV catheter system be inserted and be placed in the blood vessel; 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: Can the IV catheter system be removed properly; There is no leakage during the application of the IV catheter system (including the processes of venting, infusion, flushing and sealing, and indwelling).	up to 28 days
Secondary	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
Secondary	Indwelling time	The retention time of the IV catheter system of each subject after successful insertion.	up to 28 days
Secondary	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
Secondary	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
Secondary	Incidence of accidental dislodgement	Unintentional premature removal of the catheter from the vessel.	up to 28 days
Secondary	Incidence of phlebitis	Incidence of phlebitis	up to 28 days
Secondary	Incidence of adverse events	Incidence of adverse events	up to 28 days
Secondary	Incidence of serious adverse events	Incidence of serious adverse events	up to 28 days