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Completed

NCT Number: NCT04719377

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hunan Cancer Hospital, Changsha, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years of age;
  • Inpatient with a need for intravenous infusion for an expected period of more than 4 days but no more than 28 days;
  • The veins in the upper limbs is suitable for puncture and catheterization of both the investigational device and the control device;
  • Willing to provide written Informed Consent and complete the study per the protocol.

Exclusion criteria

  • Coagulation disorder or active bleeding;
  • Skin injury, infection, or dermatosis at the site to be punctured;
  • History of radiotherapy, thrombosis, or vascular surgery; arteriovenous fistula or phlebitis history at the area and/or vein to be catheterized;
  • History of mental illness;
  • End stage renal disease requires vein protection;
  • Conditions with decreased venous flow in the extremity, such as lymphedema of the arm, etc.;
  • 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).
  • 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.
  • Self-reported being pregnant or lactating;
  • Other conditions that the investigator considers improper for the study;
  • Participating in another study or already enrolled.

Treatment and study plan

catheter placement

Device

catheter placement

Primary outcomes

  1. Acceptance of the overall performance of the IV catheter system

    Time frame: up to 28 days

    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).

Secondary outcomes

  1. Success rate of the first insertion of the catheter

    Time frame: First day, during catheter insertion

    Successful first insertion means the IV catheter system can be successfully inserted into the blood vessel on the first insertion.

  2. Indwelling time

    Time frame: up to 28 days

    The retention time of the IV catheter system of each subject after successful insertion.

  3. Rate of good performance of the pinch clamp

    Time frame: up to 28 days

    If the pinch clamp can close and open the tubing properly, performance of the pinch clamp can be evaluated as "good".

  4. Incidence of catheter blockage

    Time frame: up to 28 days

    The catheter system is blocked, causing the system to fail to infuse the fluid after it is connected to the infusion set/syringe.

  5. Incidence of accidental dislodgement

    Time frame: up to 28 days

    Unintentional premature removal of the catheter from the vessel.

  6. Incidence of phlebitis

    Time frame: up to 28 days

    Incidence of phlebitis

  7. Incidence of adverse events

    Time frame: up to 28 days

    Incidence of adverse events

  8. Incidence of serious adverse events

    Time frame: up to 28 days

    Incidence of serious adverse events

Sponsors and collaborators

Lead sponsor

Becton, Dickinson and Company

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2021
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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