NCT04039490

Brief Summary

Clinical Trial to investigate whether the use of a novel device to be used in conjunction with ultrasound in pediatric vessel cannulations is superior to ultrasound-only pediatric vessel cannulations in terms of number of cannulation attempts.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
4.5 years until next milestone

Study Start

First participant enrolled

February 6, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

1.6 years

First QC Date

July 29, 2019

Last Update Submit

September 25, 2024

Conditions

Clinical Procedures Which Require Vessel Cannulations in Pediatric Patients

Keywords

pediatricsvessel cannulationsultrasound-guided

Outcome Measures

Primary Outcomes (1)

  • Successful first-attempt vessel cannulation

    Test if the vessel cannulation was successful with only 1 attempt --needle puncture--to reach the vessel

    1 hour

Secondary Outcomes (2)

  • Non-IR Personnel Successfully Cannulate Pediatric Patients

    1 hour

  • Point-of-Care Successful Cannulation

    1 hour

Study Arms (2)

Ultrasound-only Pediatric Vessel Cannulation

NO INTERVENTION

The standard of care for vessel cannulation currently employed at CNMC

SCENERGY-guided Pediatric Vessel Cannulation

EXPERIMENTAL

The addition of the SCENERGY guidance combined with the ultrasound for pediatric vessel cannulations.

Device: SCENERGY

Interventions

SCENERGYDEVICE

Use of the SCENERGY guidance device in conjunction with ultrasound to guide needles for pediatric vessel cannulations

SCENERGY-guided Pediatric Vessel Cannulation

Eligibility Criteria

Age1 Month - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • any pediatric patient scheduled for a vessel cannulation at CNMC

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20910, United States

RECRUITING

Central Study Contacts

Dorothee Heisenberg, PhD

CONTACT

4435703835heisenberg@clearguidemedical.com

Kevin Cleary, PhD

CONTACT

202-476-3809KCleary@childrensnational.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Because the SCENERGY is an attachment to the ultrasound probe, it cannot be masked.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: two-arm study, comparing ultrasound-only pediatric vessel cannulations versus SCENERGY-guided pediatric vessel cannulations
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2019

First Posted

July 31, 2019

Study Start

February 6, 2024

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

September 26, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)