A Clinical Trial Evaluating the Effectiveness and Safety of the PowerMe Midline Catheter in the C… (NCT04719377) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Trial Evaluating the Effectiveness and Safety of the PowerMe Midline Catheter in the Chinese Population
China256 participantsStarted 2021-01-13
Plain-language summary
This study is designed to evaluate the effectiveness and the safety of the PowerMeTM Midline Catheter in the Chinese population.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acceptance of the overall performance of the IV catheter system
. 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: