Vascular AccessSecholdNCT06938750
Novel Medical Device for Pharmacological Therapy
A study testing SECHOLD DEVICE in people with Vascular Access and Vascular Access Complication, run by Fundacion Miguel Servet at 1 site in Spain.
Trial summary
Background: Different co-creation methods were used to design and prototype a new fixative device for multiple intravenous therapies with the ability to control and identify the pharmacological therapy administered to a patient. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Vascular Access, Vascular Access Complication, Vascular Access Complications
- What is being tested?
- SECHOLD DEVICE
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jan 2023to 20 Sep 2026
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients admitted to the intensive care unit
- patients with authorization to take part in the study
Who cannot join
- Patients with pre-existing medical conditions: Patients with diseases affecting coagulation, such as hemophilia or thrombocytopathies, could be excluded.
- Active infection patients: Any patient with vascular access site infections or systemic infections may be excluded to avoid complications.
- Inability to give informed consent: Patients who are unable to understand or consent to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Navarra
Pamplona, Navarre, 31005
About this study
Official title: A Pilot Study of a Novel Medical Device for Pharmacological Therapy: The SecHold Device
Background: Different co-creation methods were used to design and prototype a new fixative device for multiple intravenous therapies with the ability to control and identify the pharmacological therapy administered to a patient. Objectives: To validate a newly created device for the reduction of complications related to the use of intravenous therapy Methods: A multidisciplinary team composed of eight professionals specializing in the field of critical care and an engineering professional in industrial design was responsible for collecting, evaluating, and materializing the ideas and needs arising from clinical practice in a device that met the standards of the same.
- Conditions
- Vascular Access, Vascular Access Complication, Vascular Access Complications, Catheter Malfunction, Catheter Infection, Therapeutic Drug Management
- Being tested
- SECHOLD DEVICE
- Keywords
- VASCULAR ACCESS, CATHETER, THERAPY, COMPLICATION, DEVICE, CENTRAL VASCULAR ACCESS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SECHOLD DEVICEDevice
PLACEMENT OF A MULTIPLE THERAPY GRIPPING DEVICE TO FIX THE DRIPPER SYSTEMS ALONG ITS PATH TO SOME SURFACE OR SPACE, AVOIDING IT TO REMAIN IN THE AIR, WITHOUT MARKING OR LABELING AND FAVORING ITS ORGANIZATION. SECHOLD is a vascular access fixation device designed for critical clinical environments such as ICU and operating rooms. It allows the simultaneous connection of 3-6 parenteral therapies to the same vascular access, ensuring clear and protocolized identification of each drug by means of labels with name, concentration and infusion range, in addition to a universal color code. This reduces the risk of drug administration errors and facilitates optimal visualization of essential information. SECHOLD also organizes infusion systems connected to the same vascular access, preventing knots and pulls that can compromise catheter integrity in case of accidental infusion bag drops.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | No intervention | FIXATION OF VASCULAR ACCESSES WITH INFUSION OF THERAPY MAINTAINED IN THE TRADITIONAL WAY, DIRECTLY TO A THREE-WAY TAP AND EXTENSION FOR CONNECTION TO A CENTRAL DEVICE. |
| INTERVENTION | Experimental | FIXATION OF VASCULAR ACCESSES WITH INFUSION OF THERAPY MAINTAINED IN THE TRADITIONAL WAY, DIRECTLY TO THREE-WAY TAP AND EXTENSION FOR CONNECTION TO CENTRAL DEVICE INCORPORATING THE SECHOLD GRIP SYSTEM FOR ATTACHMENT OF MULTIPLE DROPPERS TO IT, WITH LABELING AND ATTACHMENT TO BED/CRADLE, DROPPER STICK OR PATIENT/CARRIER CLOTHING. Receives: Device: SECHOLD DEVICE |
What is being measured
The primary outcome is the main question the study is designed to answer.
To reduce the risk of complications associated with the number of pharmacological errors.
Recognize the number of pharmacological errors (DRUG INTERACTION, WRONG DRUG, WRONG DOSAGE, WRONG SPEED) that have occurred
Measured: day 1, day 7, day 14, at 6 months after placement and start of the study
To reduce complications associated with accidental catheter withdrawals.
Number of complications associated with accidental catheter withdrawals during the study period
Measured: day 1, day 7, day 14, at 6 months after placement and start of the study
Secondary outcomes (1)
Reduce complications associated with venous catheter placement and maintenance (thrombosis, phlebitis, catheter obstruction).
Number of complications associated with venous catheter placement and maintenance (thrombosis, phlebitis, catheter obstruction)
Measured: day 1, day 7, day 14, at 6 months after placement and start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start20 Jan 2023
- Primary completion31 Jan 2026 (estimated)
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular AccessStudies 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
- A clinical trial was carried out in an intensive care unit of the University Hospital of Navarra, a tertiary hospital reference center in intensive care in Navarra, in the north of Spain; where the use and clinical validation process of a newly created device registered by European patent as a utility model was implemented. This study was made over a period of 6 months, from June 2021 to December of the same year; after internal authorization from the center where the clinical validation process has been carried out and from the local ethics committee (pyto2019/47).
- Masking
- None (open label)
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta M Ferraz-Torres, PHD, Principal investigator, Fundación Miguel Servet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938750
- Sponsor's protocol ID
- SecHold Baby
- Acronym
- Sechold
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 22 Apr 2025
- 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 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Novel Medical Device for Pharmacological Therapy: The SecHold Device
- ClinicalTrials.gov ID
- NCT06938750
- Acronym / sponsor ID
- Sechold / SecHold Baby
- Conditions
- Vascular Access, Vascular Access Complication, Vascular Access Complications, Catheter Malfunction, Catheter Infection, Therapeutic Drug Management
- Keywords
- VASCULAR ACCESS, CATHETER, THERAPY, COMPLICATION, DEVICE, CENTRAL VASCULAR ACCESS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 22 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.
Background: Different co-creation methods were used to design and prototype a new fixative device for multiple intravenous therapies with the ability to control and identify the pharmacological therapy administered to a patient. Objectives: To validate a newly created device for the reduction of complications related to the use of intravenous therapy Methods: A multidisciplinary team composed of eight professionals specializing in the field of critical care and an engineering professional in industrial design was responsible for collecting, evaluating, and materializing the ideas and needs arising from clinical practice in a device that met the standards of the same.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A clinical trial was carried out in an intensive care unit of the University Hospital of Navarra, a tertiary hospital reference center in intensive care in Navarra, in the north of Spain; where the use and clinical validation process of a newly created device registered by European patent as a utility model was implemented. This study was made over a period of 6 months, from June 2021 to December of the same year; after internal authorization from the center where the clinical validation process has been carried out and from the local ethics committee (pyto2019/47).
| Arm | Type | Receives |
|---|---|---|
| CONTROL | No intervention | –FIXATION OF VASCULAR ACCESSES WITH INFUSION OF THERAPY MAINTAINED IN THE TRADITIONAL WAY, DIRECTLY TO A THREE-WAY TAP AND EXTENSION FOR CONNECTION TO A CENTRAL DEVICE. |
| INTERVENTION | Experimental | Device: SECHOLD DEVICEFIXATION OF VASCULAR ACCESSES WITH INFUSION OF THERAPY MAINTAINED IN THE TRADITIONAL WAY, DIRECTLY TO THREE-WAY TAP AND EXTENSION FOR CONNECTION TO CENTRAL DEVICE INCORPORATING THE SECHOLD GRIP SYSTEM FOR ATTACHMENT OF MULTIPLE DROPPERS TO IT, WITH LABELING AND ATTACHMENT TO BED/CRADLE, DROPPER STICK OR PATIENT/CARRIER CLOTHING. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients admitted to the intensive care unit
- patients with authorization to take part in the study
Key exclusion criteria (3 listed)
- Patients with pre-existing medical conditions: Patients with diseases affecting coagulation, such as hemophilia or thrombocytopathies, could be excluded.
- Active infection patients: Any patient with vascular access site infections or systemic infections may be excluded to avoid complications.
- Inability to give informed consent: Patients who are unable to understand or consent to participate in the study.
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 |
|---|---|---|
| SECHOLD DEVICEPLACEMENT OF A MULTIPLE THERAPY GRIPPING DEVICE TO FIX THE DRIPPER SYSTEMS ALONG ITS PATH TO SOME SURFACE OR SPACE, AVOIDING IT TO REMAIN IN THE AIR, WITHOUT MARKING OR LABELING AND FAVORING ITS ORGANIZATION. SECHOLD is a vascular access fixation device designed for critical clinical environments such as ICU and operating rooms. It allows the simultaneous connection of 3-6 parenteral therapies to the same vascular access, ensuring clear and protocolized identification of each drug by means of labels with name, concentration and infusion range, in addition to a universal color code. This reduces the risk of drug administration errors and facilitates optimal visualization of essential information. SECHOLD also organizes infusion systems connected to the same vascular access, preventing knots and pulls that can compromise catheter integrity in case of accidental infusion bag drops. | Device | INTERVENTION |
Primary outcome
To reduce the risk of complications associated with the number of pharmacological errors.
Time frame: day 1, day 7, day 14, at 6 months after placement and start of the study
Recognize the number of pharmacological errors (DRUG INTERACTION, WRONG DRUG, WRONG DOSAGE, WRONG SPEED) that have occurred
To reduce complications associated with accidental catheter withdrawals.
Time frame: day 1, day 7, day 14, at 6 months after placement and start of the study
Number of complications associated with accidental catheter withdrawals during the study period
1 secondary outcome
Reduce complications associated with venous catheter placement and maintenance (thrombosis, phlebitis, catheter obstruction).
Time frame: day 1, day 7, day 14, at 6 months after placement and start of the study
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 22 Apr 2025.
- 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.
Marta M Ferraz-Torres, PHD principal investigator
Fundación Miguel Servet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SECHOLD DEVICE in people with Vascular Access and Vascular Access Complication, run by Fundacion Miguel Servet at 1 site in Spain.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 22 Apr 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 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?
Contact marta M FERRAZ-TORRES, PHD (+34628813974, marta.ferraz.torres@navarra.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To reduce the risk of complications associated with the number of pharmacological errors. (time frame: day 1, day 7, day 14, at 6 months after placement and start of the study). The study lists 2 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 22 Apr 2025.