Prospective Healthy Volunteer Study of the Securis™ Stabilization Device

Completed

Conditions studied: Peripheral Intavenous Catheter Stabilization

In brief

This study is being conducted to assess the performance of the Securis™ Stabilization Device in simulated clinical use.

Key facts

Study ID

NCT04841330

Run by

Becton, Dickinson and Company

People needed

104

Starts

2021-06-09

Expected to finish

2021-07-20

Last updated by the study team

2021-09-08

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• ≥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

You may not qualify if…

• 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.

Where it is running

• TKL Research, Inc — Fair Lawn, New Jersey, United States

Full record on ClinicalTrials.gov

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