Prospective Healthy Volunteer Study of the Securis™ Stabilization Device
Study Details
Study Description
Brief Summary
This study is being conducted to assess the performance of the Securis™ Stabilization Device in simulated clinical use.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Healthy volunteers A minimum of 100 healthy volunteer participants (14yo and older) |
Device: Securis™ Stabilization Device
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.
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Outcome Measures
Primary Outcome Measures
- Rate of Securis™ Stabilization Device Securement Failure During Simulated Use [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 [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
Secondary Outcome Measures
- Rate of Securis™ Stabilization Device-related Adverse Events [From placement and up to 24 hours after device removal]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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≥14 years of age, regardless of gender, at the time of informed consent
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Is expected to be available through Day 8 of the study
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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.)
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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
Exclusion Criteria:
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Significant scarring at the device application site
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Has any skin condition that might affect device adherence or the ability of study staff to perform skin assessments
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Has any condition or is taking any medication that might cause excessive bruising, bleeding, or skin tearing (e.g., anti-coagulant therapy)
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Known allergy to study device/components or ancillary devices
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Will be unable to complete a remote visit via video chat, if required
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Has any condition which, in the opinion of the Investigator, precludes them from participation in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | TKL Research, Inc | Fair Lawn | New Jersey | United States | 07410 |
Sponsors and Collaborators
- Becton, Dickinson and Company
Investigators
- Principal Investigator: Michael Casser, MD, TKL Research, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MDS-20SECUR001