Clinical trial NCT04719377: A Clinical Trial Evaluating the Effectiveness and Safety of the PowerMe Midline Catheter in the Chinese Population
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheterization
Keywords: midline
overall performance
indwelling time
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2021-01-22
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: PowerMe Midline
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptance of the overall performance of the IV catheter system
timeFrame: up to 28 days
Secondary outcomes:
measure: Success rate of the first insertion of the catheter
timeFrame: First day, during catheter insertion
measure: Indwelling time
timeFrame: up to 28 days
measure: Rate of good performance of the pinch clamp
timeFrame: up to 28 days
measure: Incidence of catheter blockage
timeFrame: up to 28 days
measure: Incidence of accidental dislodgement
timeFrame: up to 28 days
measure: Incidence of phlebitis
timeFrame: up to 28 days
measure: Incidence of adverse events
timeFrame: up to 28 days
measure: Incidence of serious adverse events
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Shanghai
country: China
facility: Shanghai First General Hospital
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
Study officials:
affiliation: Hunan Cancer Hospital, China
name: Xuying Li, RN
role: PRINCIPAL_INVESTIGATOR
References: