Prospective Healthy Volunteer Study of the Securis™ Stabilization Device

Becton, Dickinson and Company (BD)

Status: Completed

Conditions: Peripheral Intavenous Catheter Stabilization

Treatments: Device: Securis™ Stabilization Device

Study type: Observational

Funder types: Industry

Identifiers

NCT04841330

MDS-20SECUR001

Details and patient eligibility

About

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

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. ≥14 years of age, regardless of gender, at the time of informed consent
2. Is expected to be available through Day 8 of the study
3. 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.)
4. 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

1. Significant scarring at the device application site
2. Has any skin condition that might affect device adherence or the ability of study staff to perform skin assessments
3. Has any condition or is taking any medication that might cause excessive bruising, bleeding, or skin tearing (e.g., anti-coagulant therapy)
4. Known allergy to study device/components or ancillary devices
5. Will be unable to complete a remote visit via video chat, if required
6. Has any condition which, in the opinion of the Investigator, precludes them from participation in this study.

Trial design

104 participants in 1 patient group

Healthy volunteers

Description:

A minimum of 100 healthy volunteer participants (14yo and older)

Treatment:

Device: Securis™ Stabilization Device