A Study to Evaluate SU-VEID™ for Improving Peripheral Venous Access Success in Children

Use of SU-VEID™ As An Adjunct to Vein Visualization Technology to Improve Peripheral Venous Access Success in Children

The purpose of this study is to determine if use of the SU-VEID™ in children facilitates an increase success rate of peripheral intravenous starts, in comparison to the conventional method of vein entry techniques.

Study Overview

• Status: Enrolling by invitation
• Conditions: Intravenous Access
• Intervention / Treatment: Device: Single Use Vein Entry Indicator Device

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patient age < 18 years old.
• Pediatric patients in surgical pre-op (0-18 years old), requiring an I.V. catheter for surgery who are difficult venous access.
• Written informed consent/ assent from the patient or legal guardian.

Exclusion Criteria:

- Patient age > 18 years old.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard IV Insertion; Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have standard IV insertion
Other: SU-VEID assisted IV Insertion; Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have IV insertion using SU-VEID device	Device: Single Use Vein Entry Indicator Device; Electronic pressure sensing device, integrated to a conventional needle catheter, and which indicates continuously during intravenous cannulation whether the tip of the needle is inside or outside of a vein, to assist a clinician in intravenous cannulation.; Other Names: SU-VEID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IV Start first-attempt success rate	Total number of participants to have an IV access within the first attempt when using the SU-VEID Device in comparison to the conventional procedure	Baseline

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Michael Nemergut, MD, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 21-006822

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes