Status:
COMPLETED
A Clinical Trial Evaluating the Effectiveness and Safety of the PowerMe Midline Catheter in the Chinese Population
Lead Sponsor:
Becton, Dickinson and Company
Conditions:
Catheterization
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- ≥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
- 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.
Key Trial Info
Start Date :
January 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2022
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT04719377
Start Date
January 13 2021
End Date
January 30 2022
Last Update
September 23 2022
Active Locations (4)
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1
Hunan Cancer Hospital
Changsha, China
2
Shanghai First General Hospital
Shanghai, China, 200040
3
Shanghai Ninth People's Hospital
Shanghai, China
4
The First Affiliated Hospital of Soochow University
Suzhou, China