Peripherally Inserted Central CatheterNCT05278507
Comparing Arrow PICC Catheters w/ Arrowga+rd Blue Advanced Protection Performance and Safety to Unprotected PICC's
A study testing Arrowga+rd Blue Advance Protection PICC Placement in people with Peripherally Inserted Central Catheter, run by Teleflex at 5 sites in China.
Trial summary
This study seeks to compare the standard unprotected PICC with the AGBA PICC for placement success, incidence of venous thrombosis through duplex ultrasound, observing for signs and symptoms of thrombotic occlusion and recording treatment response when diagnosed by sluggish fluid flow, inability to aspirate blood and… 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?
- Arrowga+rd Blue Advance Protection PICC Placement
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 444 participants
- Where
- 5 sitesChina
- Study dates
- 16 Jan 2020to 30 Jun 2023
- 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
- Patients age ≥ 18 years requiring a PICC
- Patient will remain an inpatient for the entire dwell time
- Ability to comply with study requirements of duplex ultrasound procedures prior to and at the time of PICC removal
- Patients cognitively and physically able to give written consent to participate in the study or patient has a legally authorized representative (LAR) who may give written consent to participate in the study
Who cannot join
- Current diagnosis of venous thrombosis within the venous tract of the proposed catheter
- Diagnosis of peripheral or central vein stenosis (on proposed insertion side)
- History or diagnosis of veno-occlusive disease
- Diagnosis of superior vena cava syndrome
- Known, pre-existing diagnosis of hypercoagulation disorder unrelated to underlying disease
- Previous enrollment in this study
Show all 10Show fewer
- Currently pregnant or breast feeding
- Skin condition at or within 15 cm of the proposed catheter insertion site, including signs and symptoms of inflammation, rash, crusts, wounds with drainage, sites of intravenous infusion infiltration or extravasation, hematoma, phlebitis and or thrombophlebitis
- Medical, social, and/or psychological problems precluding subject from study participation
- Known allergy or sensitivity to chlorhexidine
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Beijing Hospital
Beijing, Doncheng District, 100730
Hui Liu
- Recruiting
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, Fengtai District, 100039
Xiu Bin Xiao
- Recruiting
Peking University Third Hospital
Beijing, Haidian District, 100191
Hong Mei Jing
- Recruiting
The First Medical Center of Chinese PLA General Hospital
Beijing, Haidian District, 100853
Dai Hong Lui
- Recruiting
Peking University People's Hospital
Beijing, Xicheng District, 100044
Xaio Hui Zhang
About this study
Official title: A Prospective, Randomized Study Comparing Device Performance Characteristics and Safety of Arrow Peripherally Inserted Central Catheters With Arrowga+rd Blue Advanced Protection to Standard Unprotected PICCs
This study seeks to compare the standard unprotected PICC with the AGBA PICC for placement success, incidence of venous thrombosis through duplex ultrasound, observing for signs and symptoms of thrombotic occlusion and recording treatment response when diagnosed by sluggish fluid flow, inability to aspirate blood and or difficulty/inability to infuse via a lumen or lumens of the catheter. The incidence of catheter-related bloodstream infection will also be tracked during the study.
Read the detailed description
The primary purpose of this study is to prospectively collect outcome data in order to evaluate the performance and safety of the Arrowga+rd Blue Advanced PICC with regard to first attempt insertion success and incidence of complications as compared to use of standard, unprotected PICC devices.
Patients will receive peripherally-inserted central catheters that are indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. Using randomization, patients will be assigned to receive the institution's standard of care uncoated/unprotected PICC or the study device, the Arrow PICC with Arrowga+rd Blue Advanced Protection
Study Device: Arrow PICC With Arrowga+rd Blue Advanced Protection:
The Arrow PICC with Arrowga+rd Blue Advanced protection (Teleflex Medical Incorporated, Morrisville, NC, USA; hereafter referred to as "AGBA") is an FDA-cleared pressure injectable device that offers both antimicrobial and anti-thrombogenic protection for at least 30 days. The application of Arrowga+rd Blue Advanced protection uses a proprietary process whereby chlorhexidine is chemically bonded to the intra- luminal catheter surfaces from tip to hub, and extra-luminal catheter body. The device is cleared for marketing in the United States of America by the Food and Drug Administration, and has obtained the CE mark for marketing in the European Union. The French size and length selected for use will be documented.
Standard of Care: The standard, unprotected PICC currently in use at the institution will be used in this study (here after referred to as Standard). The details of the PICC selected will be recorded including brand, French size, and length.
Study Design: Prospective, randomized, multicenter study
Number of Subjects: 444 subjects will be enrolled in the study and randomized to receive one of the two PICC devices.
Duration of Subject Study Participation:
Maximum of 92 days, which includes a maximum dwell time of 90 days and follow up 1 to 2 days - 9 days post PICC removal. A subject may remain in the study, with the CVC in place, beyond the expected maximum participant duration (90 days dwell, 1 - 2 day posts removal follow up) if the following conditions are met:
- On day 90 dwell, the subject requires continued PICC access, the assigned PICC remains functional, and it is in the best interest of the subject to continue access via the inserted device.
- It is in the best interest of the subject for the PICC to remain in place, due to health concerns precluding device removal.
- Conditions
- Peripherally Inserted Central Catheter
- Being tested
- Arrowga+rd Blue Advance Protection PICC Placement, Sham Comparator PICC placement
- Keywords
- PICC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arrowga+rd Blue Advance Protection PICC PlacementDevice
The PICC will be placed by a qualified healthcare professional, in accordance with institutional policies and procedures and the device's IFU.
Sham Comparator PICC placementDevice
The sham comparator PICC will be placed by a qualified healthcare professional, in accordance with institutional policies and procedures and the device's IFU.
| Study group | Role | What they receive |
|---|---|---|
| Arrow PICC With Arrowga+rd Blue Advanced Protection | Experimental | The Arrow PICC with Arrowga+rd Blue Advanced protection (Teleflex Medical Incorporated, Morrisville, NC, USA; hereafter referred to as "AGBA") is an FDA-cleared pressure injectable device that offers both antimicrobial and anti-thrombogenic protection for at least 30 days. The application of Arrowga+rd Blue Advanced protection uses a proprietary process whereby chlorhexidine is chemically bonded to the intra- luminal catheter surfaces from tip to hub, and extra-luminal catheter body. The device is cleared for marketing in the United States of America by the Food and Drug Administration, and has obtained the CE mark for marketing in the European Union. The French size and length selected for use will be documented. Receives: Device: Arrowga+rd Blue Advance Protection PICC Placement |
| Standard of Care PICC | Sham comparator | The standard, unprotected PICC currently in use at the institution will be used in this study (here after referred to as Standard). The details of the PICC selected will be recorded including brand, French size, and length. Receives: Device: Sham Comparator PICC placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt PICC insertion success
rate of first attempt insertion success = number of patients with first attempt insertion /total number of patients *100%
- First attempt insertion success and number of failed attempts will be documented
Measured: During placement
PICC Placement Success - Confirmation of tip placement in the lower 1/3 of the superior vena cava at or above the superior vena cava/right atrium junction will be performed by chest x-ray or other tip confirmation system/device and documented.
Once the PICC placement is complete, confirmation of catheter tip location in the lower 1/3 of the superior vena cava at or above the superior vena cava/right atrium junction will be performed by chest x-ray or other tip confirmation system/device and documented. Any adjustments to catheter length post-insertion must be performed using sterile technique and maximal barrier precautions. The number of adjustments to the inserted PICC needed to achieve proper tip location will be recorded.
Measured: During placement
Confirmation of tip patency by aspirating each lumen for brisk blood return and flushing each lumen with at least 10 mL of 0.9% NaCl injection USP
Once the PICC placement is complete, the inserter will confirm patency by aspirating each lumen for brisk blood return and flushing each lumen with at least 10 mL of 0.9% NaCl injection USP.
For inpatients, each lumen will be assessed for patency at least every 12 hours and/or before administration of infusion therapies. Patency assessments will be documented.
- Patency checks resulting in brisk blood return and ability to flush easily will be considered patent.
- Patency checks resulting in inability to aspirate blood with ability to flush easily will be documented as a withdrawal occlusion.
- Patency checks resulting in sluggish flow and/or ability to flush will be documented as a partial occlusion.
- Patency checks resulting in inability to aspirate blood and inability to flush will be documented as a complete occlusion.
Measured: up to 92 days
Incidence of catheter related bloodstream infection assessed by laboratory confirmed bloodstream infection
Subjects will be assessed for laboratory confirmed bloodstream infection (LCBI) as described below through one day post PICC removal
LCBI 1 Patient of any age has a recognized pathogen, which is an organism not included on the NHSN common commensal list, identified from one or more blood specimens obtained by a culture or non-culture based microbiologic testing method (excluding organisms identified by testing on sera) AND Organism(s) identified in blood is not related to an infection at another site
LCBI 2 Patient of any age has at least one of the following signs or symptoms:
fever (>38.0oC), chills, or hypotension AND Organism(s) identified in blood is not related to an infection at another site AND The same NHSN common commensal is identified by a culture or non-culture based microbiologic testing method, from two or more blood specimens collected on separate occasions.
Measured: up to 92 days
Secondary outcomes (4)
Incidence of complete loss of catheter function versus the total number of effective catheters placed
Incidence of total loss of catheter function = number of total loss of catheter function/number of effective catheter placement
Measured: up to 92 days
Incidence of catheter-associated external wall thrombosis versus the total number of effective catheters placed
Incidence of catheter-related external wall thrombosis = number of patients with catheter-related external wall thrombosis/total number of patients with effective catheter placement
Measured: up to 92 days
Device performance evaluation
Evaluate whether the accessories in the package meet the control requirements of the country and the medical institution, whether the guide wire placement is smooth, whether the catheter placement is smooth, and whether the product is smooth and satisfactory
Measured: During placement
Evaluation of other safety parameters such as Adverse Events and Device Defects during testing
- Vital signs (temperature (C), heart rate (b.p.m.), respiration rate (b.p.m.) and blood pressure (m.m.Hg) throughout the clinical study period);
- Laboratory examination (as appropriate during the evaluation process);
- The number and incidence of any related adverse events, severe adverse events during the trial
- Number and incidence of any device defects during the test
Measured: up to 92 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start16 Jan 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The primary purpose of this study is to prospectively collect outcome data in order to evaluate the performance and safety of the Arrowga+rd Blue Advanced PICC with regard to first attempt insertion success and incidence of complications as compared to use of standard, unprotected PICC devices.
- Masking
- None (open label)
- Enrolment
- 444 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teleflex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiao H Zhang, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278507
- Sponsor's protocol ID
- 2018-10
- Status last verified
- Mar 2022
- First submitted
- 21 Feb 2022
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Study protocol will be come available after the trademark has been registered to investigators whose proposed research has received IRB/EC approval
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Study Comparing Device Performance Characteristics and Safety of Arrow Peripherally Inserted Central Catheters With Arrowga+rd Blue Advanced Protection to Standard Unprotected PICCs
- ClinicalTrials.gov ID
- NCT05278507
- Acronym / sponsor ID
- 2018-10
- Conditions
- Peripherally Inserted Central Catheter
- Keywords
- PICC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 444 participants (estimated)
- Lead sponsor
- TeleflexIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 14 Mar 2022 (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 seeks to compare the standard unprotected PICC with the AGBA PICC for placement success, incidence of venous thrombosis through duplex ultrasound, observing for signs and symptoms of thrombotic occlusion and recording treatment response when diagnosed by sluggish fluid flow, inability to aspirate blood and or difficulty/inability to infuse via a lumen or lumens of the catheter. The incidence of catheter-related bloodstream infection will also be tracked during the study.
Detailed description
The primary purpose of this study is to prospectively collect outcome data in order to evaluate the performance and safety of the Arrowga+rd Blue Advanced PICC with regard to first attempt insertion success and incidence of complications as compared to use of standard, unprotected PICC devices.
Patients will receive peripherally-inserted central catheters that are indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. Using randomization, patients will be assigned to receive the institution's standard of care uncoated/unprotected PICC or the study device, the Arrow PICC with Arrowga+rd Blue Advanced Protection
Study Device: Arrow PICC With Arrowga+rd Blue Advanced Protection:
The Arrow PICC with Arrowga+rd Blue Advanced protection (Teleflex Medical Incorporated, Morrisville, NC, USA; hereafter referred to as "AGBA") is an FDA-cleared pressure injectable device that offers both antimicrobial and anti-thrombogenic protection for at least 30 days. The application of Arrowga+rd Blue Advanced protection uses a proprietary process whereby chlorhexidine is chemically bonded to the intra- luminal catheter surfaces from tip to hub, and extra-luminal catheter body. The device is cleared for marketing in the United States of America by the Food and Drug Administration, and has obtained the CE mark for marketing in the European Union. The French size and length selected for use will be documented.
Standard of Care: The standard, unprotected PICC currently in use at the institution will be used in this study (here after referred to as Standard). The details of the PICC selected will be recorded including brand, French size, and length.
Study Design: Prospective, randomized, multicenter study
Number of Subjects: 444 subjects will be enrolled in the study and randomized to receive one of the two PICC devices.
Duration of Subject Study Participation:
Maximum of 92 days, which includes a maximum dwell time of 90 days and follow up 1 to 2 days - 9 days post PICC removal. A subject may remain in the study, with the CVC in place, beyond the expected maximum participant duration (90 days dwell, 1 - 2 day posts removal follow up) if the following conditions are met:
- On day 90 dwell, the subject requires continued PICC access, the assigned PICC remains functional, and it is in the best interest of the subject to continue access via the inserted device.
- It is in the best interest of the subject for the PICC to remain in place, due to health concerns precluding device removal.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The primary purpose of this study is to prospectively collect outcome data in order to evaluate the performance and safety of the Arrowga+rd Blue Advanced PICC with regard to first attempt insertion success and incidence of complications as compared to use of standard, unprotected PICC devices.
| Arm | Type | Receives |
|---|---|---|
| Arrow PICC With Arrowga+rd Blue Advanced Protection | Experimental | Device: Arrowga+rd Blue Advance Protection PICC PlacementThe Arrow PICC with Arrowga+rd Blue Advanced protection (Teleflex Medical Incorporated, Morrisville, NC, USA; hereafter referred to as "AGBA") is an FDA-cleared pressure injectable device that offers both antimicrobial and anti-thrombogenic protection for at least 30 days. The application of Arrowga+rd Blue Advanced protection uses a proprietary process whereby chlorhexidine is chemically bonded to the intra- luminal catheter surfaces from tip to hub, and extra-luminal catheter body. The device is cleared for marketing in the United States of America by the Food and Drug Administration, and has obtained the CE mark for marketing in the European Union. The French size and length selected for use will be documented. |
| Standard of Care PICC | Sham comparator | Device: Sham Comparator PICC placementThe standard, unprotected PICC currently in use at the institution will be used in this study (here after referred to as Standard). The details of the PICC selected will be recorded including brand, French size, and length. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients age ≥ 18 years requiring a PICC
- Patient will remain an inpatient for the entire dwell time
- Ability to comply with study requirements of duplex ultrasound procedures prior to and at the time of PICC removal
- Patients cognitively and physically able to give written consent to participate in the study or patient has a legally authorized representative (LAR) who may give written consent to participate in the study
Key exclusion criteria (10 listed)
- Current diagnosis of venous thrombosis within the venous tract of the proposed catheter
- Diagnosis of peripheral or central vein stenosis (on proposed insertion side)
- History or diagnosis of veno-occlusive disease
- Diagnosis of superior vena cava syndrome
- Known, pre-existing diagnosis of hypercoagulation disorder unrelated to underlying disease
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 |
|---|---|---|
| Arrowga+rd Blue Advance Protection PICC PlacementThe PICC will be placed by a qualified healthcare professional, in accordance with institutional policies and procedures and the device's IFU. | Device | Arrow PICC With Arrowga+rd Blue Advanced Protection |
| Sham Comparator PICC placementThe sham comparator PICC will be placed by a qualified healthcare professional, in accordance with institutional policies and procedures and the device's IFU. | Device | Standard of Care PICC |
Primary outcome
First attempt PICC insertion success
Time frame: During placement
rate of first attempt insertion success = number of patients with first attempt insertion /total number of patients *100% • First attempt insertion success and number of failed attempts will be documented
PICC Placement Success - Confirmation of tip placement in the lower 1/3 of the superior vena cava at or above the superior vena cava/right atrium junction will be performed by chest x-ray or other tip confirmation system/device and documented.
Time frame: During placement
Once the PICC placement is complete, confirmation of catheter tip location in the lower 1/3 of the superior vena cava at or above the superior vena cava/right atrium junction will be performed by chest x-ray or other tip confirmation system/device and documented. Any adjustments to catheter length post-insertion must be performed using sterile technique and maximal barrier precautions. The number of adjustments to the inserted PICC needed to achieve proper tip location will be recorded.
Confirmation of tip patency by aspirating each lumen for brisk blood return and flushing each lumen with at least 10 mL of 0.9% NaCl injection USP
Time frame: up to 92 days
Once the PICC placement is complete, the inserter will confirm patency by aspirating each lumen for brisk blood return and flushing each lumen with at least 10 mL of 0.9% NaCl injection USP. For inpatients, each lumen will be assessed for patency at least every 12 hours and/or before administration of infusion therapies. Patency assessments will be documented. * Patency checks resulting in brisk blood return and ability to flush easily will be considered patent. * Patency checks resulting in inability to aspirate blood with ability to flush easily will be documented as a withdrawal occlusion. * Patency checks resulting in sluggish flow and/or ability to flush will be documented as a partial occlusion. * Patency checks resulting in inability to aspirate blood and inability to flush will be documented as a complete occlusion.
Incidence of catheter related bloodstream infection assessed by laboratory confirmed bloodstream infection
Time frame: up to 92 days
Subjects will be assessed for laboratory confirmed bloodstream infection (LCBI) as described below through one day post PICC removal LCBI 1 Patient of any age has a recognized pathogen, which is an organism not included on the NHSN common commensal list, identified from one or more blood specimens obtained by a culture or non-culture based microbiologic testing method (excluding organisms identified by testing on sera) AND Organism(s) identified in blood is not related to an infection at another site LCBI 2 Patient of any age has at least one of the following signs or symptoms: fever (>38.0oC), chills, or hypotension AND Organism(s) identified in blood is not related to an infection at another site AND The same NHSN common commensal is identified by a culture or non-culture based microbiologic testing method, from two or more blood specimens collected on separate occasions.
4 secondary outcomes
Incidence of complete loss of catheter function versus the total number of effective catheters placed
Time frame: up to 92 days
Incidence of catheter-associated external wall thrombosis versus the total number of effective catheters placed
Time frame: up to 92 days
Device performance evaluation
Time frame: During placement
Evaluation of other safety parameters such as Adverse Events and Device Defects during testing
Time frame: up to 92 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Individual participant dataSharing planned: Yes. The Study protocol will be come available after the trademark has been registered to investigators whose proposed research has received IRB/EC approval
Related trials for Peripherally Inserted Central Catheter
Not yet recruitingObservational study
Construction and Multicenter External Validation of an Early Warning Model for Asymptomatic PICC-related Upper Extremity Venous Thrombosis in Cancer Patients Based on LASSO-XGBoost
PICC-associated Thrombosis
Enrolling by invitation
Evaluating the Use of Grip Exercises to Decrease Deep Vein Thrombosis in Adult Patients With PICC Lines
Deep Vein Thrombosis
RecruitingPhase 3
Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC)
Venous Thromboembolism (VTE)
Not yet recruitingObservational study
Efficacy and Safety of Peripherally Inserted Central Venous Catheters
Critical Illness, Catheter-Related Infections
Not yet recruiting
Reduction of Complications Associated With Extraluminal PICC Management.
Treatment (ProudMe), Vascular Access
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.
Xiao H Zhang study chair
Peking University People's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arrowga+rd Blue Advance Protection PICC Placement in people with Peripherally Inserted Central Catheter, run by Teleflex at 5 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 10 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 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda Wu (15010697631, lindi.wu@teleflex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First attempt PICC insertion success (time frame: During placement). The study lists 4 primary outcomes in all. 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 Jan 2023.