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A 7 Day Adhesive Device Wear Study to Evaluate BD StatLock™ Devices

NCT04845906 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2021-09-08

No results posted yet for this study

Summary

This study is a prospective healthy human volunteer wear study to evaluate the safety and performance of the StatLock™ Catheter Stabilization Device and the StatLock™ stabilization device Accessory (Foam Strip) and to meet the design input requirements.

Conditions

  • Peripheral Intravenous Catheter Stabilization

Interventions

DEVICE

StatLock™ Catheter Stabilization Device and the StatLock™ stabilization device accessory (Foam Strip)

Each participant will have 2 separate devices applied, one to each arm, with or without a Foam Strip.The participant will also wear a dressing over top of a StatLock™ compatible catheter, which will be connected to an extension set. For this study, the catheter will not be inserted into the study participant but instead will be shortened or modified and placed on the skin and secured with the StatLock™ Stabilization Device. The use of the catheters, extension set, and the dressing represents how the device would be used in a clinical setting.

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Principal Investigators

  • Michael Casser, MD · TKL Research, Inc.

  • Gary Grove, PhD · Dermico, LLC

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-13
Primary Completion
2021-08-23
Completion
2021-08-23

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 NCT04845906 on ClinicalTrials.gov