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CompletedNCT05695183Updated Oct 10, 2023

IV SafeLock Device Functionality in Emergency Department

An interventional study of IV SafeLock in Intravenous Access, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this research study is to evaluate the functionality of the IV SafeLock in the clinical emergency department setting.

02

Conditions studied

  • Intravenous Access
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,264 studies on the registry; 670 are open to participants now.

Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.

Browse Mayo Clinic studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Emergency Department nurses who are consenting and willing to perform tasks.
  • Their patient population will include stable patients 18 or over, who present through triage, are medically stable, are able to verbally consent and require intravenous access.

Exclusion criteria

Exclusion Criteria:

  • Emergency Department nurses who are unwilling to consent to use IV SafeLock on their patient population.
  • The patient population will exclude pregnant patients, children, prisoners, patients with dementia, or any member of protected class as specified by IRB.
  • The patients must be medically stable and not include patients presenting with acute stroke, acute myocardial infarction, severe sepsis or shock.
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Emergency Department Nurses

    Registered nurses will use the IV SafeLock Device on patients during care in the emergency department.

    Device: IV SafeLock

Interventions

  • DeviceIV SafeLock

    Designed to prevent patient access to intravenous lines in the hospital setting. The device locks with an institution specific key and protects the hub as well as all tubing access points.

06

What researchers measure

Primary outcomes

  1. Functionality of the IV SafeLock

    Measured on a likert scale for nurse evaluation of IV SafeLock

    Time frame: Baseline

07

Study locations

1 site
  • Mayo Clinic Florida
    Jacksonville, Florida 32224, United States
08

References and documents

Publications

  • Bragg K, Albus M, Bragg B, Beste RM, Simon LV. Evaluation of the Functionality in an Emergency Department Setting of an Intravenous Protection Device to Prevent Self-Injection. Med Devices (Auckl). 2024 Mar 19;17:135-142. doi: 10.2147/MDER.S451439. eCollection 2024. PubMed 38529519 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05695183
Lead sponsor
Mayo Clinic
Responsible party
Kara J. Bragg (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jan 23, 2023
Start date
Jul 22, 2023
Primary completion
Oct 6, 2023
Completion
Oct 6, 2023
Last update
Oct 10, 2023

Study contacts

Kara Bragg, APRN, DNP
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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