Prospective Healthy Volunteer Study of the Securis™ Stabilization Device

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.

Inclusion criteria

• ≥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

Exclusion criteria

• 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.