CatheterizationNCT04719377
A Clinical Trial Evaluating the Effectiveness and Safety of the PowerMe Midline Catheter in the Chinese Population
A study testing catheter placement in people with Catheterization, run by Becton, Dickinson and Company at 4 sites in China.
Trial summary
This study is designed to evaluate the effectiveness and the safety of the PowerMeTM Midline Catheter in the Chinese population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheterization
- What is being tested?
- catheter placement
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 4 sitesChina
- Study dates
- 13 Jan 2021to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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.;
Show all 14Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Hunan Cancer Hospital
Changsha
Shanghai First General Hospital
Shanghai, 200040
Shanghai Ninth People's Hospital
Shanghai
The First Affiliated Hospital of Soochow University
Suzhou
About this study
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
This study is designed to evaluate the effectiveness and the safety of the PowerMeTM Midline Catheter in the Chinese population.
Read the 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
- Being tested
- catheter placement
- Keywords
- midline, overall performance, indwelling time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter placementDevice
catheter placement
| Study group | Role | What they receive |
|---|---|---|
| Powerme midline catheter | Experimental | Powerme midline catheter Receives: Device: catheter placement |
| peripheral intravenous catheter | Sham comparator | BD Pegusas peripheral intravenous catheter Receives: Device: catheter placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance of the overall performance of the IV catheter system
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).
Measured: up to 28 days
Secondary outcomes (8)
Success rate of the first insertion of the catheter
Successful first insertion means the IV catheter system can be successfully inserted into the blood vessel on the first insertion.
Measured: First day, during catheter insertion
Indwelling time
The retention time of the IV catheter system of each subject after successful insertion.
Measured: up to 28 days
Rate of good performance of the pinch clamp
If the pinch clamp can close and open the tubing properly, performance of the pinch clamp can be evaluated as "good".
Measured: up to 28 days
Incidence of catheter blockage
The catheter system is blocked, causing the system to fail to infuse the fluid after it is connected to the infusion set/syringe.
Measured: up to 28 days
Incidence of accidental dislodgement
Unintentional premature removal of the catheter from the vessel.
Measured: up to 28 days
Incidence of phlebitis
Incidence of phlebitis
Measured: up to 28 days
Incidence of adverse events
Incidence of adverse events
Measured: up to 28 days
Incidence of serious adverse events
Incidence of serious adverse events
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start13 Jan 2021
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PowerMe Midline
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xuying Li, RN, Principal investigator, Hunan Cancer Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719377
- Sponsor's protocol ID
- CDC-19POWME01
- Status last verified
- Sep 2022
- First submitted
- 28 Dec 2020
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04719377
- Acronym / sponsor ID
- CDC-19POWME01
- Conditions
- Catheterization
- Keywords
- midline, overall performance, indwelling time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- PowerMe Midline
| Arm | Type | Receives |
|---|---|---|
| Powerme midline catheter | Experimental | Device: catheter placementPowerme midline catheter |
| peripheral intravenous catheter | Sham comparator | Device: catheter placementBD Pegusas peripheral intravenous catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| catheter placementcatheter placement | Device | Powerme midline catheter, peripheral intravenous catheter |
Primary outcome
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).
8 secondary outcomes
Success rate of the first insertion of the catheter
Time frame: First day, during catheter insertion
Indwelling time
Time frame: up to 28 days
Rate of good performance of the pinch clamp
Time frame: up to 28 days
Incidence of catheter blockage
Time frame: up to 28 days
Incidence of accidental dislodgement
Time frame: up to 28 days
Incidence of phlebitis
Time frame: up to 28 days
Incidence of adverse events
Time frame: up to 28 days
Incidence of serious adverse events
Time frame: up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuying Li, RN principal investigator
Hunan Cancer Hospital, China
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing catheter placement in people with Catheterization, run by Becton, Dickinson and Company at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance of the overall performance of the IV catheter system (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.