Prospective Healthy Volunteer Study of the Securis™ Stabilization Device

NCT ID: NCT04841330

Last Updated: 2021-09-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-09
• Study Completion Date: 2021-07-20

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.

Conditions

Peripheral Intavenous Catheter Stabilization

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy volunteers

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

Securis™ Stabilization Device

Intervention Type: DEVICE

A trained clinician will apply and remove, and participants will wear the Securis™ Stabilization Device for up to one week (7 days) on their forearm. A shortened catheter will be placed (not inserted) over the Securis™ device in accordance with the product Information for Use (IFU), and an extension set attached to the catheter and secured in place, to simulate clinical use.

Interventions

Securis™ Stabilization Device

A trained clinician will apply and remove, and participants will wear the Securis™ Stabilization Device for up to one week (7 days) on their forearm. A shortened catheter will be placed (not inserted) over the Securis™ device in accordance with the product Information for Use (IFU), and an extension set attached to the catheter and secured in place, to simulate clinical use.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Becton, Dickinson and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Casser, MD

Role: PRINCIPAL_INVESTIGATOR

TKL Research, Inc.

Locations

TKL Research, Inc

Fair Lawn, New Jersey, United States

Countries

United States

Other Identifiers

MDS-20SECUR001

Identifier Type: -

Identifier Source: org_study_id