Vascular Access DevicesFLUSH-ETINCT07519304

Effectiveness of a Needle-free Connector With Anti-reflux Technology in Reducing Complications From Long Peripheral Venous Catheters in Hospitalised Adult Patients: Randomised Clinical Trial

A study testing Needle-free connector with neutral fluid displacement and without anti-reflux technology, Needle-free connector with neutral fluid displacement and equipped with anti-reflux technology and Long peripheral venous catheter in people with Vascular Access Devices and Catheters, run by Hospital Arnau de Vilanova at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

A study to evaluate a needle-free connector (a stopper) featuring anti-reflux technology (to prevent blood from flowing back) for catheters (polyurethane tubes inserted into a vein), with the aim of reducing complications associated with these devices: blockages, infections, pain, etc. Read more about this study

Who is it for?: Any age
Conditions the study is for: Vascular Access Devices, Catheters, Occlusion
What is being tested?: Needle-free connector with neutral fluid displacement and without anti-reflux technology, Needle-free connector with neutral fluid displacement and equipped with anti-reflux technology and Long peripheral venous catheter
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteSpain
Study dates: 20 Apr 2026to 31 Jan 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients requiring placement of a long peripheral venous catheter.
Patients who have provided written informed consent.
Patients with an expected hospital stay of ≥7 days.

Who cannot join

Inability to place a long peripheral venous catheter in the upper limbs.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Arnau de Vilanova University Hospital in Lleida
Lleida, Lleida, 25198

Other trials in Spain

About this study

Read the detailed description

Introduction: Long peripheral venous catheters (PVCs) are a suitable alternative to short PVCs, midline catheters (MLCs) and central venous catheters (CVCs), particularly in patients with difficult intravenous access (DIVA), due to their characteristics: they are between 6 and 15 centimetres in length, have a gauge of 18 to 22 gauge (G), and do not extend beyond the axillary vein.

Hypothesis: The use of a needle-free connector with neutral fluid displacement and equipped with anti-reflux technology (Clave™ Neutron™) in long PVCs in adult inpatients with acute conditions reduces the number of catheter failures during the first seven days compared with a neutral-displacement needle-free connector without an anti-reflux valve.

Objective: To evaluate the efficacy of using a needle-free connector with neutral fluid displacement and equipped with anti-reflux technology (Clave™ Neutron™) following the insertion of long PVCs in adult inpatients in the acute phase of their illness during the first seven days.

Methodology: A clinical study involving two randomised groups will be conducted prior to catheter placement. The control group will receive treatment using a needle-free connector with neutral fluid displacement and without an anti-reflux valve (Microclave® Clear, Ref. 011-MC3302). The intervention group will receive treatment using a needle-free connector with neutral fluid displacement and equipped with anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139).

Expected results: It is expected that the incidence of complications associated with long PVCs in hospitalised adult patients will be reduced following the standardised implementation of a needle-free connector with neutral fluid displacement and equipped with anti-reflux technology (Clave™ Neutron™) during the initial phase of treatment. Specifically, a reduction in the incidence of catheter obstructions and CRBSI is anticipated.

Clinical implication: The study will contribute to optimising decision-making regarding catheter maintenance and related therapeutic measures, with the aim of reducing the main complications associated with them.

Conditions: Vascular Access Devices, Catheters, Occlusion, Thrombosis, Randomised Controlled Trial
Being tested: Needle-free connector with neutral fluid displacement and without anti-reflux technology, Needle-free connector with neutral fluid displacement and equipped with anti-reflux technology, Long peripheral venous catheter, Ultrasound scanner
Keywords: Needleless connector
Medical subject headings: Bites and Stings, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Needle-free connector with neutral fluid displacement and without anti-reflux technologyProcedure or surgery
Placement of a needle-free connector with neutral fluid displacement and no anti-reflux technology onto a long PVC.
Needle-free connector with neutral fluid displacement and equipped with anti-reflux technologyProcedure or surgery
Placement of a needle-free connector featuring neutral fluid displacement and anti-reflux technology onto a long PVC.
Long peripheral venous catheterDevice
Placement of a 20-gauge long PVC in an arm vein using the AST.
Ultrasound scannerOther
All punctures will be performed under ultrasound guidance.

Study groups in NCT07519304
Study group	Role	What they receive
Needle-free connector without anti-reflux technology	Active comparator	Insertion of a long peripheral venous catheters (PVCs) using the accelerated Seldinger technique (AST), followed by placement of a needle-free connector with neutral fluid displacement and no anti-reflux technology (Microclave® Clear, Ref. 011-MC3302). Receives: Procedure: Needle-free connector with neutral fluid displacement and without anti-reflux technology; Device: Long peripheral venous catheter; Other: Ultrasound scanner
Needle-free connector with anti-reflux technology	Experimental	Insertion of a long PVCs using the AST, followed by placement of a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139). Receives: Procedure: Needle-free connector with neutral fluid displacement and equipped with anti-reflux technology; Device: Long peripheral venous catheter; Other: Ultrasound scanner

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants who experienced device-related adverse events, classified according to CTCAE v5.0.
Percentage of participants experiencing adverse events following insertion of a long peripheral venous catheter and placement of a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139).
Measured: 7 days

Secondary outcomes (1)

Number of participants with partial or complete occlusions in long peripheral venous catheters, as assessed using the CINAS scale (UZ Leuven®).
To determine the total number of partial and complete occlusions in long peripheral venous catheters in adult inpatients during the acute phase of illness within the first seven days after insertion of either a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™) or a neutral connector without this technology.
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Apr 202631 Jan 2027

First posted9 Apr 2026
Study start20 Apr 2026
Primary completion31 Dec 2026 (estimated)
Study completion31 Jan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
Other trials for Vascular Access DevicesStudies 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: Parallel groups
Model description: A classic parallel-group design will be used, consisting of an intervention group and a control group. The intervention group will receive catheters fitted with a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139), whereas the control group will receive a needle-free connector with neutral fluid displacement but without anti-reflux technology (Microclave® Clear, Ref. 011-MC3302).
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 62 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07519304
Sponsor's protocol ID: 04/25
Acronym: FLUSH-ETI
Status last verified: Sep 2026
First submitted: 2 Apr 2026
Last updated: 21 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Krath J, Fredskilde J, Christensen SK, Baltsen CD, Valentin K, Offersen R, Juhl-Olsen P. The performance and complications of long peripheral venous catheters: A retrospective single-centre study. Acta Anaesthesiol Scand. 2024 Nov;68(10):1463-1470. doi: 10.1111/aas.14517. Epub 2024 Aug 26.
PubMed 39183695
Goossens GA, De Waele Y, Jerome M, Fieuws S, Janssens C, Stas M, Moons P. Diagnostic accuracy of the Catheter Injection and Aspiration (CINAS) classification for assessing the function of totally implantable venous access devices. Support Care Cancer. 2016 Feb;24(2):755-761. doi: 10.1007/s00520-015-2839-x. Epub 2015 Jul 26.
PubMed 26209949
U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE) v.5.0. Cancer Ther Eval Progr [Internet]. 2017;155. Available from: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcae_v5_quick_reference_5x7.pdf
Schulz KF, Altman DG, Moher D; Consort Group. [CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials (Chinese version)]. Zhong Xi Yi Jie He Xue Bao. 2010 Jul;8(7):604-12. doi: 10.3736/jcim20100702. Chinese.
PubMed 20619135
Valentino R, Farkas V. Maximizing the Midline [Internet]. AVA. 2015 [cited 2025 Jul 16]. p. 1. Available from: https://nexusmedical.com/wp-content/uploads/2021/04/nexus-medical-poster-25-valentino-farkas-maximizing-the-midline-new-york-methodist-hospital-2015-ava-national-conference.pdf
ICU medical. Observational In-Vivo Evaluation of the NeutronTM Needlefree Catheter Patency Device and its Effects on Catheter Occlusions in a Home Care Setting [Internet]. icumed.com; 2011. p. 1-2. Available from: https://www.icumed.com/media/ddqd4cgy/p23-5809_neutron-catheter-patency-and-occlusions-home-care-setting_web.pdf
Moureau N, Gorski L, Flynn J, Johnson K. A Systematic Review of Needleless Connector Function and Occlusion Outcomes: Evidence Leading the Way. J Infus Nurs. 2025 Mar-Apr 01;48(2):84-105. doi: 10.1097/NAN.0000000000000578. Epub 2025 Mar 6.
PubMed 40047605
Nexus medical. Nexus TKO® Technology [Internet]. nexusmedical.com. 2022 [cited 2025 Jul 16]. p. 1-10. Available from: https://nexusmedical.com/tko-technology/
ICU medical. ClaveTM NeutronTM: Anti-Reflux Neutral Displacement Needlefree Connector [Internet]. https://www.icumed.com/. 2025 [cited 2025 Jul 16]. p. 1-13. Available from: https://www.icumed.com/products/infusion-therapy/infusion-consumables/iv-connectors/clave-neutron/
Brodnik JE, Lieux SM, Serrano-Smith M, Bena JF, Siedlecki SL. PICC Line Occlusions: Implications and Opportunities for Medical-Surgical Nurses. MEDSURG Nurs [Internet]. 2023;32(5):305. Available from: https://www.jannettipublications.com/journal/470987/volume/474881/article/474947
Weber Y, Cohn-Schwartz D, Khamis S, Neuberger A, Berger G. Safety and efficacy of a new long peripheral catheter in hospitalized patients - a retrospective observational study. SAGE Open Med. 2025 Apr 29;13:20503121251337197. doi: 10.1177/20503121251337197. eCollection 2025.
PubMed 40309318
Gilardi E, Giannuzzi R, WoldeSellasie K, Piano A, Pittiruti M, Scoppettuolo G. Mini-midline in difficult intravenous access patients in emergency department: A prospective analysis. J Vasc Access. 2020 Jul;21(4):449-455. doi: 10.1177/1129729819883129. Epub 2019 Oct 24.
PubMed 31647353
Gilardi E, Grandi T, Giannuzzi R, Valletta F, Fugger S, Mazzaroppi S, Petrucci M, Piano A, Piccioni A, WoldeSellasie K, Sambuco F, Travaglino F. Long peripheral cannula in COVID-19 patients: 769 catheter days experience from a semi-intensive respiratory COVID unit. J Vasc Access. 2024 Mar;25(2):498-503. doi: 10.1177/11297298221115002. Epub 2022 Sep 5.
PubMed 36065094
Yuan M, Li J, Shao W, Xu C, Luo N, Wang H. Evaluating the impact train-the-trainer program in nurse training for mini-midline catheter insertion. BMC Med Educ. 2025 Mar 17;25(1):389. doi: 10.1186/s12909-025-06975-5.
PubMed 40091028
Fabiani A, Aversana N, Santoro M, Calandrino D, Liotta P, Sanson G. The longer the catheter, the lower the risk of complications: Results of the HERITAGE study comparing long peripheral and midline catheters. Am J Infect Control. 2024 Nov;52(11):1289-1295. doi: 10.1016/j.ajic.2024.06.019. Epub 2024 Jun 27.
PubMed 38944156

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of a Needle-free Connector With Anti-reflux Technology in Reducing Complications From Long Peripheral Venous Catheters in Hospitalised Adult Patients: Randomised Clinical Trial
ClinicalTrials.gov ID: NCT07519304
Acronym / sponsor ID: FLUSH-ETI / 04/25
Conditions: Vascular Access Devices, Catheters, Occlusion, Thrombosis, Randomised Controlled Trial
Keywords: Needleless connector
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 62 participants (estimated)
Lead sponsor: Hospital Arnau de VilanovaUniversity, hospital or other
Collaborators: Official College of Nurses of Lleida, Department of Health, Generalitat de Catalunya
Study start: 20 Apr 2026 (actual)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 31 Jan 2027 (estimated)
First posted: 9 Apr 2026 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: A classic parallel-group design will be used, consisting of an intervention group and a control group. The intervention group will receive catheters fitted with a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139), whereas the control group will receive a needle-free connector with neutral fluid displacement but without anti-reflux technology (Microclave® Clear, Ref. 011-MC3302).

Arm	Type	Receives
Needle-free connector without anti-reflux technology	Active comparator	Procedure: Needle-free connector with neutral fluid displacement and without anti-reflux technology, Device: Long peripheral venous catheter, Other: Ultrasound scannerInsertion of a long peripheral venous catheters (PVCs) using the accelerated Seldinger technique (AST), followed by placement of a needle-free connector with neutral fluid displacement and no anti-reflux technology (Microclave® Clear, Ref. 011-MC3302).
Needle-free connector with anti-reflux technology	Experimental	Procedure: Needle-free connector with neutral fluid displacement and equipped with anti-reflux technology, Device: Long peripheral venous catheter, Other: Ultrasound scannerInsertion of a long PVCs using the AST, followed by placement of a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139).

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Patients requiring placement of a long peripheral venous catheter.
Patients who have provided written informed consent.
Patients with an expected hospital stay of ≥7 days.

Key exclusion criteria (1 listed)

Inability to place a long peripheral venous catheter in the upper limbs.

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
Needle-free connector with neutral fluid displacement and without anti-reflux technologyPlacement of a needle-free connector with neutral fluid displacement and no anti-reflux technology onto a long PVC.	Procedure or surgery	Needle-free connector without anti-reflux technology
Needle-free connector with neutral fluid displacement and equipped with anti-reflux technologyPlacement of a needle-free connector featuring neutral fluid displacement and anti-reflux technology onto a long PVC.	Procedure or surgery	Needle-free connector with anti-reflux technology
Long peripheral venous catheterPlacement of a 20-gauge long PVC in an arm vein using the AST.	Device	Needle-free connector with anti-reflux technology, Needle-free connector without anti-reflux technology
Ultrasound scannerAll punctures will be performed under ultrasound guidance.	Other	Needle-free connector with anti-reflux technology, Needle-free connector without anti-reflux technology

Primary outcome

Number of participants who experienced device-related adverse events, classified according to CTCAE v5.0.
Time frame: 7 days
Percentage of participants experiencing adverse events following insertion of a long peripheral venous catheter and placement of a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139).

1 secondary outcome

Number of participants with partial or complete occlusions in long peripheral venous catheters, as assessed using the CINAS scale (UZ Leuven®).
Time frame: 7 days

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
Background: PubMed 39183695Krath J, Fredskilde J, Christensen SK, Baltsen CD, Valentin K, Offersen R, Juhl-Olsen P. The performance and complications of long peripheral venous catheters: A retrospective single-centre study. Acta Anaesthesiol Scand. 2024 Nov;68(10):1463-1470. doi: 10.1111/aas.14517. Epub 2024 Aug 26.
Background: PubMed 26209949Goossens GA, De Waele Y, Jerome M, Fieuws S, Janssens C, Stas M, Moons P. Diagnostic accuracy of the Catheter Injection and Aspiration (CINAS) classification for assessing the function of totally implantable venous access devices. Support Care Cancer. 2016 Feb;24(2):755-761. doi: 10.1007/s00520-015-2839-x. Epub 2015 Jul 26.
BackgroundU.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE) v.5.0. Cancer Ther Eval Progr [Internet]. 2017;155. Available from: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcae_v5_quick_reference_5x7.pdf
Background: PubMed 20619135Schulz KF, Altman DG, Moher D; Consort Group. [CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials (Chinese version)]. Zhong Xi Yi Jie He Xue Bao. 2010 Jul;8(7):604-12. doi: 10.3736/jcim20100702. Chinese.
BackgroundValentino R, Farkas V. Maximizing the Midline [Internet]. AVA. 2015 [cited 2025 Jul 16]. p. 1. Available from: https://nexusmedical.com/wp-content/uploads/2021/04/nexus-medical-poster-25-valentino-farkas-maximizing-the-midline-new-york-methodist-hospital-2015-ava-national-conference.pdf
BackgroundICU medical. Observational In-Vivo Evaluation of the NeutronTM Needlefree Catheter Patency Device and its Effects on Catheter Occlusions in a Home Care Setting [Internet]. icumed.com; 2011. p. 1-2. Available from: https://www.icumed.com/media/ddqd4cgy/p23-5809_neutron-catheter-patency-and-occlusions-home-care-setting_web.pdf
Background: PubMed 40047605Moureau N, Gorski L, Flynn J, Johnson K. A Systematic Review of Needleless Connector Function and Occlusion Outcomes: Evidence Leading the Way. J Infus Nurs. 2025 Mar-Apr 01;48(2):84-105. doi: 10.1097/NAN.0000000000000578. Epub 2025 Mar 6.
BackgroundNexus medical. Nexus TKO® Technology [Internet]. nexusmedical.com. 2022 [cited 2025 Jul 16]. p. 1-10. Available from: https://nexusmedical.com/tko-technology/
BackgroundICU medical. ClaveTM NeutronTM: Anti-Reflux Neutral Displacement Needlefree Connector [Internet]. https://www.icumed.com/. 2025 [cited 2025 Jul 16]. p. 1-13. Available from: https://www.icumed.com/products/infusion-therapy/infusion-consumables/iv-connectors/clave-neutron/
BackgroundBrodnik JE, Lieux SM, Serrano-Smith M, Bena JF, Siedlecki SL. PICC Line Occlusions: Implications and Opportunities for Medical-Surgical Nurses. MEDSURG Nurs [Internet]. 2023;32(5):305. Available from: https://www.jannettipublications.com/journal/470987/volume/474881/article/474947
Background: PubMed 40309318Weber Y, Cohn-Schwartz D, Khamis S, Neuberger A, Berger G. Safety and efficacy of a new long peripheral catheter in hospitalized patients - a retrospective observational study. SAGE Open Med. 2025 Apr 29;13:20503121251337197. doi: 10.1177/20503121251337197. eCollection 2025.
Background: PubMed 31647353Gilardi E, Giannuzzi R, WoldeSellasie K, Piano A, Pittiruti M, Scoppettuolo G. Mini-midline in difficult intravenous access patients in emergency department: A prospective analysis. J Vasc Access. 2020 Jul;21(4):449-455. doi: 10.1177/1129729819883129. Epub 2019 Oct 24.
Individual participant dataSharing planned: Yes

Related trials for Vascular Access Devices

Active, not recruiting
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Enrolling by invitation
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Impact of a Long Peripheral Venous Catheter Protocol in Pediatric and Neonatal Care
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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?

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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. 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 Spain. 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?

This study is still under way. Results are not available in the source record yet.

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?

Number of participants who experienced device-related adverse events, classified according to CTCAE v5.0. (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07519304, which also lists 28 linked publications.

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 21 Sep 2026.