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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04719377
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : February 10, 2022
Sponsor:
Information provided by (Responsible Party):
Becton, Dickinson and Company

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

Condition or disease Intervention/treatment Phase
Catheterization Device: catheter placement Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: PowerMe Midline
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 13, 2021
Actual Primary Completion Date : January 30, 2022
Estimated Study Completion Date : June 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Powerme midline catheter
Powerme midline catheter
 Device: catheter placement
catheter placement
Sham Comparator: peripheral intravenous catheter
BD Pegusas peripheral intravenous catheter
 Device: catheter placement
catheter placement


Outcome Measures
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Primary Outcome Measures :
  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:

    1. Can the IV catheter system vent the air properly;
    2. Can the IV catheter system be inserted and be placed in the blood vessel;

    3. 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:

    4. Can the IV catheter system be removed properly;
    5. There is no leakage during the application of the IV catheter system (including the processes of venting, infusion, flushing and sealing, and indwelling).


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04719377


Contacts
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Contact: Xiaoxia Zhu +86-21- 2325 4853 justina.zhu@bd.com
Contact: Xiaoshan Shan xiaoshan.shan@bd.com

Locations
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China
Hunan Cancer Hospital Recruiting
Changsha, China
Contact: Xuying Li         
Shanghai First General Hospital Not yet recruiting
Shanghai, China, 200040
Contact: Hong Xing         
Shanghai Ninth People's Hospital Not yet recruiting
Shanghai, China
Contact: Lili Hou         
The First Affiliated Hospital of Soochow University Not yet recruiting
Suzhou, China
Contact: Lan Xu         
Sponsors and Collaborators
Becton, Dickinson and Company
Investigators
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Principal Investigator: Xuying Li, RN Hunan Cancer Hospital, China
More Information
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Responsible Party: Becton, Dickinson and Company
ClinicalTrials.gov Identifier: NCT04719377    
Other Study ID Numbers: CDC-19POWME01
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Becton, Dickinson and Company:
midline
overall performance
indwelling time