HealthyFLEXITNCT06927141
Effect of Flexible Catheter Materials on Catheter Angle and Blood Vessel Irritation
A study testing Bilateral Peripheral Intravenous Catheterisation in people with Healthy and Intravenous Catheterization, run by Griffith University at 1 site in Australia.
Trial summary
Peripheral intravenous catheters (PIVCs; commonly known as "cannulas") are very small tubes made out of rubber-like materials which are inserted into patients' arms using a needle to allow easy access to veins. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Intravenous Catheterization, Oedema
- What is being tested?
- Bilateral Peripheral Intravenous Catheterisation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteAustralia
- Study dates
- 26 May 2025to 9 Oct 2025
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult aged 18-75 years.
- Not pregnant at time of recruitment and within 48 hrs of Day 1 procedures (self-reported)
- Normal haematology results as per reference range determined by the laboratory.
- Normal coagulation results as per reference range determined by the laboratory.
- Target cephalic veins readily cannulatable (i.e., > 2 mm)
- Able and willing to provide verbal and written consent
- Must be an Australian citizen with current Medicare card
Who cannot join
- History of pro coagulative state / condition (e.g., previous deep vein thrombosis)
- Currently on any anti-coagulant or platelet inhibitor medication. Use of NSAIDs and aspirin will be documented however are not exclusionary.
- Haemophilia or any current or history of bleeding disorder or tendency
- Presence or report of current blood borne disease/infection (e.g., hepatitis, HIV, leukemia, lymphoma)
- History of difficult vascular access
- Allergy or sensitivity to chlorhexidine gluconate, isopropyl alcohol, latex, or skin adhesives
Show all 11Show fewer
- BMI < 18.5 kg/m2 or ≥ 35 kg/m2
- Positive results for the urine drug screen at screening or check-in (including opiates, methadone, cocaine, amphetamines)
- History or presence of alcoholism (self-reported) or drug abuse within the past 2 years
- A current or previous medical, physical, mental / cognitive disorder or anatomical conditions that, in the opinion of the chief or sub-investigator, would place the patient at risk, would make them unable to perform study procedures or has the potential to confound interpretation of the study results. (e.g., musculo-skeletal injury, chronic back pain)
- Employed by Terumo, Becton Dickinson, Teleflex Medical, ICUMedical or BBraun (conflict of interest)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Flexible Catheter Materials on Catheter Angle, Dwell Time, Thrombosis and Interstitial Oedema
Peripheral intravenous catheters (PIVCs; commonly known as "cannulas") are very small tubes made out of rubber-like materials which are inserted into patients' arms using a needle to allow easy access to veins. They are the most commonly-used medical devices in the world, with almost 10 million placed each year in Australia alone. Approximately 40% (almost 4 million) of these devices stop working (i.e. fail) prior to completion of therapy.
The main goal of this study is to learn if softer, more flexible PIVC tip materials reduce the angle of the catheter tip on the vein surface compared to less flexible materials. Reducing the angle of the tip is believed to reduce rubbing on the inner vein surface and causing irritation, extending the life of the catheter. Other goals of this study are to learn if softer materials affect: volume of oedema (i.e. fluid leakage around the vein); time until catheter failure; clot volume in the vein; changes in vein size in response to catheter insertion; adverse event rates (i.e. changes in rates of specific, reportable symptoms); and determining if certain catheters are better for some people than others. This study is recruiting participants of all genders aged 18 - 75 years old who:
Read more
- Are not pregnant
- Have a Body Mass Index (BMI) between 18.5 - 35 kg/m2
- Have a current Australian Medicare card
- Do not have a history of chronic/infectious disease or clotting disorders
- Do not have a history of recreational drug use or alcohol abuse within the past 2 years
Participants will:
- Spend two hours in the clinic for screening blood collection, medical questionnaire and ultrasound imaging of veins
- Have one more flexible catheter and one less flexible catheter placed in opposite arms (i.e. participants will have a total of two catheters placed) which will remain in place either (i) until they fail or (ii) for 72 hours, whichever is earlier
- Spend eight hours per day in the clinic on the day the catheters are placed and the two days following for observation and ultrasound imaging
- Spend four hours in the clinic on the third day following placement of the catheters for observation, ultrasound imaging and catheter removal
- Spend one hour in the clinic 24-96 hours after catheter removal for a follow-up assessment and questionnaire
- Conditions
- Healthy, Intravenous Catheterization, Oedema, Thrombosis
- Being tested
- Bilateral Peripheral Intravenous Catheterisation
- Keywords
- Catheter Angle, Interstitial Oedema, Peripheral Intravenous Catheter, Catheter Materials, Indwell, Cannulation, FLEXIT, Vascular Access Device
- Medical subject headings
- Edema, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Peripheral Intravenous CatheterisationDevice
Also called Cannulation
Participants will have peripheral intravenous catheters inserted. Each participant will receive two different catheters (less flexible = 20 gauge ICUMedical SuperCath5 SP120-20-31T; more flexible = 20 gauge Becton Dickinson Insyte Autoguard Blood Control 381034), with the treatment arm (more flexible) being randomly assigned.
| Study group | Role | What they receive |
|---|---|---|
| Left More Flexible Right Less Flexible | Experimental | Participants in this arm will have a more flexible catheter placed in their left arm. Receives: Device: Bilateral Peripheral Intravenous Catheterisation |
| Left Less Flexible Right More Flexible | Experimental | Participants in this arm will have a less flexible catheter placed in their left arm. Receives: Device: Bilateral Peripheral Intravenous Catheterisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter Angle
Measured against inferior border of vein using vascular ultrasound (in degrees)
Measured: Baseline (Day 1: morning)
Secondary outcomes (5)
Volume of interstitial oedema
Measured using vascular ultrasound (in mm cubed/microliters)
Measured: Morning visit (AM) after catheter insertion through to final interventional visit (up to 4 days)
Time to catheter failure
Measured separately for each PIVC (in hours), including differences between catheters and survival analysis.
Measured: Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier)
Thrombus volume in vein
Measured using vascular ultrasound (in mm cubed/microliters)
Measured: Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier)
Vein segment volume
Measured by vascular ultrasound (in mm cubed/microliters)
Measured: Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier)
Adverse Events
Identified by study team and/or nurses and reviewed by a medical practitioner (identified individually and aggregate of all adverse events; expressed as a count and percentage of catheters inserted).
Measured: Morning visit (AM) after catheter insertion through to follow-up visit (up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start26 May 2025
- Primary completion8 Sep 2025
- Study completion9 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two catheters are being compared simultaneously using a bilateral cannulation model. Participants will be randomised for which catheter will be inserted into either arm, but all participants will be cannulated with both catheters. The randomisation algorithm will be designed to ensure that left- and right-hand dominant participants are distributed evenly across treatment arms.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Griffith University
- Sponsor type
- University, hospital or other
- Collaborators
- Queensland University of Technology, University of Galway, Poitiers University Hospital, Terumo Corporation, Queensland Health
- Responsible party
- Principal investigator, Andrew Bulmer, Griffith University
- Investigators
- Principal Investigator, Principal investigator, Griffith University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927141
- Sponsor's protocol ID
- 2025/150
- Acronym
- FLEXIT
- Status last verified
- Nov 2025
- First submitted
- 27 Mar 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication in an international peer-reviewed journal
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Flexible Catheter Materials on Catheter Angle, Dwell Time, Thrombosis and Interstitial Oedema
- ClinicalTrials.gov ID
- NCT06927141
- Acronym / sponsor ID
- FLEXIT / 2025/150
- Conditions
- Healthy, Intravenous Catheterization, Oedema, Thrombosis
- Keywords
- Catheter Angle, Interstitial Oedema, Peripheral Intravenous Catheter, Catheter Materials, Indwell, Cannulation, FLEXIT, Vascular Access Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Griffith UniversityUniversity, hospital or other
- Collaborators
- Queensland University of Technology, University of Galway, Poitiers University Hospital, Terumo Corporation, Queensland Health
- Study start
- 26 May 2025 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 9 Oct 2025 (actual)
- First posted
- 15 Apr 2025 (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.
Peripheral intravenous catheters (PIVCs; commonly known as "cannulas") are very small tubes made out of rubber-like materials which are inserted into patients' arms using a needle to allow easy access to veins. They are the most commonly-used medical devices in the world, with almost 10 million placed each year in Australia alone. Approximately 40% (almost 4 million) of these devices stop working (i.e. fail) prior to completion of therapy.
The main goal of this study is to learn if softer, more flexible PIVC tip materials reduce the angle of the catheter tip on the vein surface compared to less flexible materials. Reducing the angle of the tip is believed to reduce rubbing on the inner vein surface and causing irritation, extending the life of the catheter. Other goals of this study are to learn if softer materials affect: volume of oedema (i.e. fluid leakage around the vein); time until catheter failure; clot volume in the vein; changes in vein size in response to catheter insertion; adverse event rates (i.e. changes in rates of specific, reportable symptoms); and determining if certain catheters are better for some people than others. This study is recruiting participants of all genders aged 18 - 75 years old who:
- Are not pregnant
- Have a Body Mass Index (BMI) between 18.5 - 35 kg/m2
- Have a current Australian Medicare card
- Do not have a history of chronic/infectious disease or clotting disorders
- Do not have a history of recreational drug use or alcohol abuse within the past 2 years
Participants will:
- Spend two hours in the clinic for screening blood collection, medical questionnaire and ultrasound imaging of veins
- Have one more flexible catheter and one less flexible catheter placed in opposite arms (i.e. participants will have a total of two catheters placed) which will remain in place either (i) until they fail or (ii) for 72 hours, whichever is earlier
- Spend eight hours per day in the clinic on the day the catheters are placed and the two days following for observation and ultrasound imaging
- Spend four hours in the clinic on the third day following placement of the catheters for observation, ultrasound imaging and catheter removal
- Spend one hour in the clinic 24-96 hours after catheter removal for a follow-up assessment and questionnaire
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two catheters are being compared simultaneously using a bilateral cannulation model. Participants will be randomised for which catheter will be inserted into either arm, but all participants will be cannulated with both catheters. The randomisation algorithm will be designed to ensure that left- and right-hand dominant participants are distributed evenly across treatment arms.
| Arm | Type | Receives |
|---|---|---|
| Left More Flexible Right Less Flexible | Experimental | Device: Bilateral Peripheral Intravenous CatheterisationParticipants in this arm will have a more flexible catheter placed in their left arm. |
| Left Less Flexible Right More Flexible | Experimental | Device: Bilateral Peripheral Intravenous CatheterisationParticipants in this arm will have a less flexible catheter placed in their left arm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult aged 18-75 years.
- Not pregnant at time of recruitment and within 48 hrs of Day 1 procedures (self-reported)
- Normal haematology results as per reference range determined by the laboratory.
- Normal coagulation results as per reference range determined by the laboratory.
- Target cephalic veins readily cannulatable (i.e., > 2 mm)
Key exclusion criteria (11 listed)
- History of pro coagulative state / condition (e.g., previous deep vein thrombosis)
- Currently on any anti-coagulant or platelet inhibitor medication. Use of NSAIDs and aspirin will be documented however are not exclusionary.
- Haemophilia or any current or history of bleeding disorder or tendency
- Presence or report of current blood borne disease/infection (e.g., hepatitis, HIV, leukemia, lymphoma)
- History of difficult vascular access
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 |
|---|---|---|
| Bilateral Peripheral Intravenous CatheterisationAlso: CannulationParticipants will have peripheral intravenous catheters inserted. Each participant will receive two different catheters (less flexible = 20 gauge ICUMedical SuperCath5 SP120-20-31T; more flexible = 20 gauge Becton Dickinson Insyte Autoguard Blood Control 381034), with the treatment arm (more flexible) being randomly assigned. | Device | Left Less Flexible Right More Flexible, Left More Flexible Right Less Flexible |
Primary outcome
Catheter Angle
Time frame: Baseline (Day 1: morning)
Measured against inferior border of vein using vascular ultrasound (in degrees)
5 secondary outcomes
Volume of interstitial oedema
Time frame: Morning visit (AM) after catheter insertion through to final interventional visit (up to 4 days)
Time to catheter failure
Time frame: Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier)
Thrombus volume in vein
Time frame: Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier)
Vein segment volume
Time frame: Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier)
Adverse Events
Time frame: Morning visit (AM) after catheter insertion through to follow-up visit (up to 7 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 20 Nov 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication in an international peer-reviewed journal
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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.
Principal Investigator principal investigator
Griffith University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Peripheral Intravenous Catheterisation in people with Healthy and Intravenous Catheterization, run by Griffith University at 1 site in Australia.
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 7 inclusion and 11 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 20 Nov 2025. 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 Australia. 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?
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?
Catheter Angle (time frame: Baseline (Day 1: morning)). 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 20 Nov 2025.