Peripherally Inserted Central CatheterNCT03230357
Research on the Localization Accuracy of PICC Guided by EDUG in Real World
A study testing PICC guided by EDUG in people with Peripherally Inserted Central Catheter, run by Shandong Branden Med.Device Co.,Ltd at 1 site in China.
Trial summary
This study is a multi-center clinical study, 3000 cases, 25 centers in the country involved, carry out the guidance of EDUG PICC standardized operation at the same period. Each center assists to use app to collect research data.The experimental data will be collected, processed and analyzed by the sponsor and the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripherally Inserted Central Catheter
- What is being tested?
- PICC guided by EDUG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 2 May 2017to 2 Aug 2018
- 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
- Patient≥18 years old
- Follow the doctor's advice,patients who need to be placed PICC for the first time.
- No serious cardiovascular diseases, such as atrial fibrillation,pulmonary heart disease and other P wave abnormalities, severe heart block, etc.
- Patients who did not participate in other clinical studies；
- Patients who volunteer to participate the clinical study, sign the informed consent and cooperate with the clinical follow-up.
Who cannot join
- Patients who have partial deformity or scar formation
- Patients whose puncture site were infected or damaged
- Patients who have sclerosis or the cord like change of the vein
- Patients have compressed vessel by tumor
- Patients who are confirmed or suspected having infection, bacteremia, or sepsis related to the catheter
- Patients whose size are not fit to insert the PICC
Show all 14Show fewer
- Patients who are confirmed or suspected sensitive to silica gel
- Patients who have history of radiotherapy in the pre-insertion section
- Patients who have history of venous thrombosis, trauma, or vascular surgery
- Patients who have superior vena cava syndrome
- Patients who were always not following up with the doctors
- Patients who have severe peripheral edema
- Patients who may be required a high flow of fluid infusion, hemodialysis, pacemaker, crutches or A-V fistulation
- -
Trial locations and contacts
1 site in 1 country.
About this study
This study is a multi-center clinical study, 3000 cases, 25 centers in the country involved, carry out the guidance of EDUG PICC standardized operation at the same period. Each center assists to use app to collect research data.The experimental data will be collected, processed and analyzed by the sponsor and the researchers, and the clinical effect of EDUG will be evaluated according to the results (like the rate of once in place, the number of adjustment times before X-ray, the length of time during the whole catheter placement, the ectopic incidence during PICC first implantation and so on, the special content can be seen in the next indicator section)
- Conditions
- Peripherally Inserted Central Catheter
- Being tested
- PICC guided by EDUG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICC guided by EDUGDevice
ECG Doppler ultrasound guidance technology (EDUG) is the combination of MST puncture and ECG technology through the use of ECG Doppler ultrasound machine and valve conduction PICC to conform the localization of EDUG technology by the study of real-world
| Study group | Role | What they receive |
|---|---|---|
| PICC guided by EDUG | Experimental | PICC(Peripherally Inserted Central Catheter)guided by ECG Doppler ultrasonic Guidance（EDUG),EDUG is a combination device which can be used for selecting the right vein and precise positioning for the catheter tip during the PICC cathetering. Receives: Device: PICC guided by EDUG |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of once in place
judge weather the catheter tip location guided by the EDUG is accuracy by compare the results with the Xray
Measured: From the date of admitting to hospital until completion of the trial, up to 6 months.
Secondary outcomes (6)
the number of adjustment times before X-ray
the totally number of adjustment times during the once operation guided by EDUG
Measured: From the date of admitting until discharge to hospital, up to 14 days.
the length of time during the whole catheter placement before X-ray
the whole length of time during the once operation guided by EDUG
Measured: From the date of admitting until discharge to hospital, up to 14 days.
the number of cathetering times after X-ray
the totally number of cathetering times during the operation guided by EDUG until the cather tip can be guided to the right location
Measured: From the date of admitting until discharge to hospital, up to 14 days.
record the adverse events
the adverse events including bleeding, infection , thrombosis and so on
Measured: 0,24,48,72 hours and 7days after completing the whole cathetering operation; Every 7 days from completing the whole cathering operation until tube drawing whichever came first, assessed up to 1 year
Patient acceptance
The patient who is in line with the discharge criteria and intends to enter the study shall record whether or not he has agreed to accept the operation plan and complete the operation
Measured: From the date of admitting until discharge to hospital, up to 14 days.
the convenience of the operation
App questionnaire was used to collect the convenience and comfort of PICC operators
Measured: From the date of admitting until discharge to hospital, up to 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start2 May 2017
- Primary completion2 Feb 2018 (estimated)
- Study completion2 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripherally Inserted Central CatheterStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Branden Med.Device Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Qilu Hospital of Shandong University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230357
- Sponsor's protocol ID
- Branden-edug
- Status last verified
- Jul 2017
- First submitted
- 10 Jul 2017
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Localization Accuracy of PICC Guided by EDUG in Real World
- ClinicalTrials.gov ID
- NCT03230357
- Acronym / sponsor ID
- Branden-edug
- Conditions
- Peripherally Inserted Central Catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shandong Branden Med.Device Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Qilu Hospital of Shandong University
- Study start
- 2 May 2017 (actual)
- Primary completion
- 2 Feb 2018 (estimated)
- Study completion
- 2 Aug 2018 (estimated)
- First posted
- 26 Jul 2017 (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 a multi-center clinical study, 3000 cases, 25 centers in the country involved, carry out the guidance of EDUG PICC standardized operation at the same period. Each center assists to use app to collect research data.The experimental data will be collected, processed and analyzed by the sponsor and the researchers, and the clinical effect of EDUG will be evaluated according to the results (like the rate of once in place, the number of adjustment times before X-ray, the length of time during the whole catheter placement, the ectopic incidence during PICC first implantation and so on, the special content can be seen in the next indicator section)
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PICC guided by EDUG | Experimental | Device: PICC guided by EDUGPICC(Peripherally Inserted Central Catheter)guided by ECG Doppler ultrasonic Guidance（EDUG),EDUG is a combination device which can be used for selecting the right vein and precise positioning for the catheter tip during the PICC cathetering. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient≥18 years old
- Follow the doctor's advice,patients who need to be placed PICC for the first time.
- No serious cardiovascular diseases, such as atrial fibrillation,pulmonary heart disease and other P wave abnormalities, severe heart block, etc.
- Patients who did not participate in other clinical studies；
- Patients who volunteer to participate the clinical study, sign the informed consent and cooperate with the clinical follow-up.
Key exclusion criteria (14 listed)
- Patients who have partial deformity or scar formation
- Patients whose puncture site were infected or damaged
- Patients who have sclerosis or the cord like change of the vein
- Patients have compressed vessel by tumor
- Patients who are confirmed or suspected having infection, bacteremia, or sepsis related to the catheter
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 |
|---|---|---|
| PICC guided by EDUGECG Doppler ultrasound guidance technology (EDUG) is the combination of MST puncture and ECG technology through the use of ECG Doppler ultrasound machine and valve conduction PICC to conform the localization of EDUG technology by the study of real-world | Device | PICC guided by EDUG |
Primary outcome
the rate of once in place
Time frame: From the date of admitting to hospital until completion of the trial, up to 6 months.
judge weather the catheter tip location guided by the EDUG is accuracy by compare the results with the Xray
6 secondary outcomes
the number of adjustment times before X-ray
Time frame: From the date of admitting until discharge to hospital, up to 14 days.
the length of time during the whole catheter placement before X-ray
Time frame: From the date of admitting until discharge to hospital, up to 14 days.
the number of cathetering times after X-ray
Time frame: From the date of admitting until discharge to hospital, up to 14 days.
record the adverse events
Time frame: 0,24,48,72 hours and 7days after completing the whole cathetering operation; Every 7 days from completing the whole cathering operation until tube drawing whichever came first, assessed up to 1 year
Patient acceptance
Time frame: From the date of admitting until discharge to hospital, up to 14 days.
the convenience of the operation
Time frame: From the date of admitting until discharge to hospital, up to 14 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICC guided by EDUG in people with Peripherally Inserted Central Catheter, run by Shandong Branden Med.Device Co.,Ltd at 1 site 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 5 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: status not confirmed, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
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?
the rate of once in place (time frame: From the date of admitting to hospital until completion of the trial, up to 6 months.). 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 26 Jul 2017.