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

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

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

Study Overview

• Status: Completed
• Conditions: Catheterization
• Intervention / Treatment: Device: catheter placement

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Changsha, China
    • Hunan Cancer Hospital
  • Shanghai, China
    • Shanghai Ninth People's Hospital
  • Shanghai, China, 200040
    • Shanghai First General Hospital
  • Suzhou, China
    • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Powerme midline catheter	Device: catheter placement; catheter placement
Sham Comparator: peripheral intravenous catheter; BD Pegusas peripheral intravenous catheter	Device: catheter placement; catheter placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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 Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company
• Investigators: Principal Investigator: Xuying Li, RN, Hunan Cancer Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2021
• Primary Completion (Actual): January 30, 2022
• Study Completion (Actual): January 30, 2022

Study Registration Dates

• First Submitted: December 28, 2020
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: midline; overall performance; indwelling time
• Other Study ID Numbers: CDC-19POWME01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No