Status:
COMPLETED
Prospective Healthy Volunteer Study of the Securis™ Stabilization Device
Lead Sponsor:
Becton, Dickinson and Company
Conditions:
Peripheral Intavenous Catheter Stabilization
Eligibility:
All Genders
14+ years
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. Part...
Eligibility Criteria
Inclusion
- ≥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
- 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.
Key Trial Info
Start Date :
June 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 20 2021
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04841330
Start Date
June 9 2021
End Date
July 20 2021
Last Update
September 8 2021
Active Locations (1)
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1
TKL Research, Inc
Fair Lawn, New Jersey, United States, 07410