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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04719377
Other study ID # CDC-19POWME01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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