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

Becton, Dickinson and Company (BD)

Status: Completed

Conditions: Catheterization

Treatments: Device: catheter placement

Study type: Interventional

Funder types: Industry

Identifiers

NCT04719377

CDC-19POWME01

Details and patient eligibility

About

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

Full 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.

Enrollment: 256 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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256 participants in 2 patient groups

Powerme midline catheter

Experimental group

Description:

Powerme midline catheter

Treatment:

Device: catheter placement

peripheral intravenous catheter

Sham Comparator group

Description:

BD Pegusas peripheral intravenous catheter

Treatment:

Device: catheter placement