Peripheral Intavenous Catheter StabilizationNCT04841330
Prospective Healthy Volunteer Study of the Securis™ Stabilization Device
An observational study of Peripheral Intavenous Catheter Stabilization, run by Becton, Dickinson and Company at 1 site in United States.
Trial summary
This study is being conducted to assess the performance of the Securis™ Stabilization Device in simulated clinical use. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Intavenous Catheter Stabilization
- What is being tested?
- Securis™ Stabilization Device
- Type of treatment
- Medical device
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2021to 20 Jul 2021
- Phase
- Observational
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Potential participants will be recruited from healthy volunteer participant pools identified and/or held by the study site.
Who may be able to join
- ≥14 years of age, regardless of gender, at the time of informed consent
- Is expected to be available through Day 8 of the study
- Is expected to understand and follow the study procedures including applicable restrictions in activities (e.g., limited physical exercise, no swimming, no use of lotions/moisturizers, etc.)
- Provision of signed and dated informed consent form. Note: Consent of a parent of legal guardian will be require for participants <18 years of age; assent will also be required for these participants
Who cannot join
- Significant scarring at the device application site
- Has any skin condition that might affect device adherence or the ability of study staff to perform skin assessments
- Has any condition or is taking any medication that might cause excessive bruising, bleeding, or skin tearing (e.g., anti-coagulant therapy)
- Known allergy to study device/components or ancillary devices
- Will be unable to complete a remote visit via video chat, if required
- Has any condition which, in the opinion of the Investigator, precludes them from participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
This study is being conducted to assess the performance of the Securis™ Stabilization Device in simulated clinical use.
Read the detailed description
This study is designed to collect prospective observational data related to the safety and performance of the Securis™ Stabilization Device in healthy volunteers utilizing a simulated use method. Participants will have an intravenous catheter applied (not inserted) onto their forearm with a Securis™ Stabilization Device applied over it. The site/device will be assessed over a period of 9 days (ideally Days 0-7 in-clinic and Day 8 virtually). The assessments will include the appearance of the site, the appearance of the dressing, and the movement of the catheter tip under the dressing.
- Being tested
- Securis™ Stabilization Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Securis™ Stabilization DeviceDevice
A trained clinician will apply and remove, and participants will wear the Securis™ Stabilization Device for up to one week (7 days) on their forearm. A shortened catheter will be placed (not inserted) over the Securis™ device in accordance with the product Information for Use (IFU), and an extension set attached to the catheter and secured in place, to simulate clinical use.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | A minimum of 100 healthy volunteer participants (14yo and older) Receives: Device: Securis™ Stabilization Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Securis™ Stabilization Device Securement Failure During Simulated Use
Device securement failure is defined as any of the following:
- Loose dressing
- Soiled under dressing
- Complete failure (complete removal)
- Dislodgement of device or catheter
Measured: From time of placement and up to 8 days after removal
Percentage of Participants with Select Skin Conditions Observed During Securis™ Stabilization Device Use
Select skin conditions include any of the following:
- Blister
- Rash
- Skin tear
- Bruising
- Exudate
Measured: From placement and up tp to 24 hours after device removal
Secondary outcomes (1)
Rate of Securis™ Stabilization Device-related Adverse Events
Rate of device-related adverse events calculated as the number of participants with adverse events related to the device divided by the total number of evaluable participants.
Measured: From placement and up to 24 hours after device removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start9 Jun 2021
- Primary completion20 Jul 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Intavenous Catheter StabilizationStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Casser, MD, Principal investigator, TKL Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841330
- Sponsor's protocol ID
- MDS-20SECUR001
- Status last verified
- Sep 2021
- First submitted
- 8 Apr 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Healthy Volunteer Study of the Securis™ Stabilization Device
- ClinicalTrials.gov ID
- NCT04841330
- Acronym / sponsor ID
- MDS-20SECUR001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to assess the performance of the Securis™ Stabilization Device in simulated clinical use.
Detailed description
This study is designed to collect prospective observational data related to the safety and performance of the Securis™ Stabilization Device in healthy volunteers utilizing a simulated use method. Participants will have an intravenous catheter applied (not inserted) onto their forearm with a Securis™ Stabilization Device applied over it. The site/device will be assessed over a period of 9 days (ideally Days 0-7 in-clinic and Day 8 virtually). The assessments will include the appearance of the site, the appearance of the dressing, and the movement of the catheter tip under the dressing.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Device: Securis™ Stabilization DeviceA minimum of 100 healthy volunteer participants (14yo and older) |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Potential participants will be recruited from healthy volunteer participant pools identified and/or held by the study site.
Key inclusion criteria (4 listed)
- ≥14 years of age, regardless of gender, at the time of informed consent
- Is expected to be available through Day 8 of the study
- Is expected to understand and follow the study procedures including applicable restrictions in activities (e.g., limited physical exercise, no swimming, no use of lotions/moisturizers, etc.)
- Provision of signed and dated informed consent form. Note: Consent of a parent of legal guardian will be require for participants <18 years of age; assent will also be required for these participants
Key exclusion criteria (6 listed)
- Significant scarring at the device application site
- Has any skin condition that might affect device adherence or the ability of study staff to perform skin assessments
- Has any condition or is taking any medication that might cause excessive bruising, bleeding, or skin tearing (e.g., anti-coagulant therapy)
- Known allergy to study device/components or ancillary devices
- Will be unable to complete a remote visit via video chat, if required
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 |
|---|---|---|
| Securis™ Stabilization DeviceA trained clinician will apply and remove, and participants will wear the Securis™ Stabilization Device for up to one week (7 days) on their forearm. A shortened catheter will be placed (not inserted) over the Securis™ device in accordance with the product Information for Use (IFU), and an extension set attached to the catheter and secured in place, to simulate clinical use. | Device | Healthy volunteers |
Primary outcome
Rate of Securis™ Stabilization Device Securement Failure During Simulated Use
Time frame: From time of placement and up to 8 days after removal
Device securement failure is defined as any of the following: * Loose dressing * Soiled under dressing * Complete failure (complete removal) * Dislodgement of device or catheter
Percentage of Participants with Select Skin Conditions Observed During Securis™ Stabilization Device Use
Time frame: From placement and up tp to 24 hours after device removal
Select skin conditions include any of the following: * Blister * Rash * Skin tear * Bruising * Exudate
1 secondary outcome
Rate of Securis™ Stabilization Device-related Adverse Events
Time frame: From placement and up to 24 hours after device removal
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 8 Sep 2021.
- Individual participant dataSharing planned: Undecided
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.
Michael Casser, MD principal investigator
TKL Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Intavenous Catheter Stabilization, run by Becton, Dickinson and Company at 1 site in United States.
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 6 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 8 Sep 2021. 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 United States. 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?
Rate of Securis™ Stabilization Device Securement Failure During Simulated Use (time frame: From time of placement and up to 8 days after removal). 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 8 Sep 2021; AzTrials last refreshed its copy on 6 Nov 2026.