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Prospective Healthy Volunteer Study of the Securis™ Stabilization Device

NCT04841330 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 104

Last updated 2021-09-08

No results posted yet for this study

Summary

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

Conditions

  • Peripheral Intavenous Catheter Stabilization

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Principal Investigators

  • Michael Casser, MD · TKL Research, Inc.

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-09
Primary Completion
2021-07-20
Completion
2021-07-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04841330 on ClinicalTrials.gov