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

NCT05204082 | Terminated Results FDA Device

• 1 other identifier: 21-006822
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intravenous Access

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With IV Access at First Attempt

  Percentage of participants to have an IV access within the first attempt when using the SU-VEID Device in comparison to the conventional procedure

  Baseline

Study Arms (2)

Standard IV Insertion

NO INTERVENTION

Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have standard IV insertion

SU-VEID assisted IV Insertion

OTHER

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

Interventions

Single Use Vein Entry Indicator Device 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.

Also known as: SU-VEID

SU-VEID assisted IV Insertion

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- Patient age \> 18 years old.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Limitations and Caveats

Study terminated due to the the available SU-VEID devices expiring and the inability to acquire additional devices for study completion.

Results Point of Contact

• Title: Michael E. Nemergut, M.D., Ph.D.
• Organization: Mayo Clinic

Nemergut.Michael@mayo.edu

507-255-7976

Study Officials

• Michael Nemergut, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: March 28, 2022
• Primary Completion: July 21, 2022
• Study Completion: July 21, 2022
• Last Updated: May 23, 2024
• Results First Posted: May 23, 2024

Record last verified: 2024-05

Locations

US (1)