Clinical trial NCT04841330: Prospective Healthy Volunteer Study of the Securis™ Stabilization Device
Official title: Prospective Healthy Volunteer Study of the Securis™ Stabilization Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Intavenous Catheter Stabilization
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2021-04-12
Enrollment: 104
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants will be recruited from healthy volunteer participant pools identified and/or held by the study site.

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Securis™ Stabilization Device Securement Failure During Simulated Use
timeFrame: From time of placement and up to 8 days after removal
measure: Percentage of Participants with Select Skin Conditions Observed During Securis™ Stabilization Device Use
timeFrame: From placement and up tp to 24 hours after device removal
Secondary outcomes:
measure: Rate of Securis™ Stabilization Device-related Adverse Events
timeFrame: From placement and up to 24 hours after device removal
Other outcomes:
Locations:
city: Fair Lawn
country: United States
facility: TKL Research, Inc
state: New Jersey
Study officials:
affiliation: TKL Research, Inc.
name: Michael Casser, MD
role: PRINCIPAL_INVESTIGATOR
References: