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

NCT ID: NCT04719377

Last Updated: 2022-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-13
• Study Completion Date: 2022-01-30

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.

Conditions

Catheterization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Powerme midline catheter

Powerme midline catheter

Group Type: EXPERIMENTAL

catheter placement

Intervention Type: DEVICE

catheter placement

peripheral intravenous catheter

BD Pegusas peripheral intravenous catheter

Group Type: SHAM_COMPARATOR

catheter placement

Intervention Type: DEVICE

catheter placement

Interventions

catheter placement

catheter placement

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Becton, Dickinson and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xuying Li, RN

Role: PRINCIPAL_INVESTIGATOR

Hunan Cancer Hospital, China

Locations

Hunan Cancer Hospital

Changsha, , China

Shanghai First General Hospital

Shanghai, , China

Shanghai Ninth People's Hospital

Shanghai, , China

The First Affiliated Hospital of Soochow University

Suzhou, , China

Countries

China

Other Identifiers

CDC-19POWME01

Identifier Type: -

Identifier Source: org_study_id